CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`202236Orig1s000
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`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`F°rm Approved: OMB NO- 0910'0513
`Department of Health and Human Services
`Expiration Date: 7/31/10
`Food and Dru Administration
`See OMB Statement on Page 3,
`9
`PATENT iNFORMATION SUBMITTED WITH THE FILING NDANUMBER
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`NAME OF APPL'CANT/NDA HOLDER
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition) Meda Pharmaceu‘lcals
`and/or Method of Use
`Meda Pharmaceuticals Inc.
`
`The following is provided'In accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`
`TRADENAME Nasal)Spray
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`ACTIVE INGREDIENT(S
`azelastine hydrochloride
`fluticasone propionate
`
`I O
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`Nasal Spray
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`STRENGTH(S)
`I37 mcg per spray
`50 mcg per spray
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`This patent declaration formlS required to be submitted to the Food and Drug Administration(F(DA) with an NDA application
`amendment or supplement as required by 21 CFR 31453 at the address providedIn 21 CFR 31453(d)(4)
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the
`only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: lf additional space is required for any narrative answer (i.e., one that
`does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`FDA will not list patent information if you submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`1. GENERAL
`
`a. United States Patent Number
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`b Issue Date of Patent
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`c. Expiration Date of Patent
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`d. Name of Patent Owner
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`Address (of Patent Owner)
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`City/State
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`ZIP Code 1 FAX Number(ifavailable)
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`E—Mail Address (if available)
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`Telephone Number
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`e. ‘ameo agen or represen a we w o reSI-es or maIn aIns
`a place of Busmess WIthIn the United States authorized to
`receive notice of patent certification under section 505(b)(3)
`and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (if patent owner or NDA
`applicant/holder does not reside or have a place of
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`business within the United States)
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`‘ - oress 0 agent or representatlve name
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`Qty/State
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`ZIP Code
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`Telephone Number
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`’ FAX Number(ifavailable)
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`E-Mail Address (if available)
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`st e patent re erence above a patent that has een submitted previous y or the
`approved NDA or supplement referenced above?
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`9.
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`t e patent re erenceo a-ove as ueen su-chtte previous y or listing, is the expiration
`date a new expiration date?
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`FORM FDA 3542a (12/08)
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`Page 1
`PSC (I‘mphics~ (30“ 44.14090
`EF
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`Reference ID: 3127881
`Reference ID: 3127881
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`

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`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendment, or supplement.
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`2. Drug Substance (Active Ingredient)
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`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`described in the pending NDA, amendment, or supplement?
`D Yes
`D No
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`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the pending NDA, amendment, or supplement?
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`D No
`(:1 Yes
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`2.3 if the answer to question 2.2 is "Yes," do you certify that, as of the date of this declaration, you have test
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`data demonstrating that a drug product containing the polymorph will perform the same as the drug product
`.
`described in the NBA? The type of test data required is described at 21 CFR 314.53(b).
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`:] Yes
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`D No
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`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
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`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
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`(Complete the information in section 4 below if the patent claims a pending method of using the pending
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`drug product to administer the metabolite )
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`2.6 Does the patent claim only an intermediate?
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`E] No
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`E] No
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`2.7 If the patent referenced'in 2.1 is a product-by—-process patent, is the product claimedIn the
`patent novel? (An answer is required only if the patent is a product—by-process patent)
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`D Yes
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`E] No
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`3. Drug Product (Composition/Formulation)
`3.1 Does the patent claim the drug product as defined in 21 CFR 314.3, in the pending NDA, amendment,
`or supplement?
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`3.2 Does the patent claim only an intermediate?
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`:] Yes
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`3 Yes
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`3.3 If the patent referenced'In 3.1 is a product-by-process patent, is the product claimed in the
`patent novel? (An answer is required only if the patent is a product—by-process patent.)
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`4. Method of Use
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` Sponsors must submit the information in section 4 for each method of using the pending drug product for which approval is being
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`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
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`4.1 Does the patent claim one or more methods of use for which approval is being sought in
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`the pending NDA, amendment, or supplement?
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`Does (Do) the patent claim(s) referenced in 4.2 claim a
`4.2 Patent Claim Number(s) (as listed in the patent)
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`
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`pending method of use for which approval is being sought
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`in the pending NDA, amendment, or supplement?
`E] Yes
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`
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`4.23 If the answer to 4.2 is
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
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`
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`“Yes," identify with speci—
`ficity the use with refer-
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`ence to the proposed
`labeling for the drug
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`product.
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`5. No Relevant Patents
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`For this pending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
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`drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and with respect to which
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`a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the
`manufacture, use, or sale of the drug product.
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`
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`FORM FDA 3542a (12I08)
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`'
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`Page 2
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`Reference ID: 3127881
`Reference ID: 3127881
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`6. Declaration Certification
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`6-1 The undersigned declares that this is an accurate and complete submission ofpatent information for the NDA,
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`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
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`sensitive patent information is submitted pursuant to 21 CFR 314.53. [attest that I am familiar with 21 CFR 314.53 and
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`this submission complies with the requirements of the regulation. 1 verify under penalty of perjury that the foregoing is
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`true and correct.
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`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
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`6.2 Authorized Signature of NBA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
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`otherAuthorized Official) (Provlde Information below)
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`Date Signed
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`NOTE: Only an NBA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant]
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`holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
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`elm,
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`Check applicable box and provide information below.
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`E NDA Applicant's/Holder's Attorney, Agent (Representative) or other
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`Authorized Official
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`1: Patent Owner’s Attorney, Agent (Representative) or Other Authorized
`[:l Patent Owner
`Official
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`Richard Fosko, RPh, MPH, Senior Director Regulatory Affairs, Meda Pharmaceuticals Inc.
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`Address
`City/State
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`’
`Somerset, NJ
`265 Davidson Ave, Suite 300
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`ZIP Code
`Telephone Number
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`08873-4120
`732-564-2358
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`E—Mail Address (if available)
`FAX Number (if available)
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`732-564-2377
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`richard.fosko@meda.us
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`The public reporting burden for this collection of information has been estimated to average 20 hours per response, including the time for reviewing
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`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
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`Department of Health and Human Services
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`Food and Drug Administration
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`Office of Chief Information Officer (HFA-710)
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`5600 Fishers Lane
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`Rockville, MD 20857
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` An agency may not conduct or sponsor. and a person is not required to respond to. a collection of
`information unless it displays a currently valid OMB control number.
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`Z] NDA Applicant/Holder
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`Name
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`FORM FDA 35423 (12/08)
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`Page 3
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`Reference ID: 3127881
`Reference ID: 3127881
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`

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`1.3. Administrative Information
`
`PATENT CERTIFICATIONS
`
`The patent for azelastine hydrochloride in Meda Pharmaceuticals’ product ASTELIN® Nasal
`Spray (NDA 20-114) expires on May 1, 2011.
`
`According to the information in the Food and Drug Administration Orange Book Database
`(http://www.accessdata.fda.gov/scripts/Cder/ob/docs/querytn.cfm), there are no unexpired patents
`for FLONASE® (fluticasone propionate) Nasal Spray (NDA 20—121, Glaxo Smith Kline).
`
`In accordance with 21 CFR 314.94(a)(12), Meda Pharmaceuticals presents the following
`certification.
`
`PARAGRAPH II CERTIFICATION:
`
`In accordance with 21 CFR 314.94(a)(12)(i)(2), Meda Pharmaceuticals certifies that, to the best
`of its knowledge, that the patent for FLONASE® (fluticasone propionate) Nasal Spray expired in
`May 2004.
`
`W W
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`246-301)
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`Richard Fosko, RPh, MPH
`Senior Director, Regulatory Affairs
`Meda Pharmaceuticals Inc
`
`Date
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`Reference ID: 3127881
`Reference ID: 3127881
`
`

`

`EXCLUSIVITY SUMMARY
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`
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`SUPPL #
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`HFD # 570
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`Dymista
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`azelastine hydrochloride/fluticasone proprionate
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`NDA # 202236
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`Trade Name:
`
`Generic Name:
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`Applicant Name:
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`Approval Date, If Known May 1, 2012
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`Meda Pharmaceuticals
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`PART I
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
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`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
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`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
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` YES
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`NO
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`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
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`505(b)(2)
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`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
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` YES
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`NO
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`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
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`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
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`Reference ID: 3124530
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`Page 1
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`d) Did the applicant request exclusivity?
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` YES
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`NO
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`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
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`3 years
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`e) Has pediatric exclusivity been granted for this Active Moiety?
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` YES
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`NO
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` If the answer to the above question in YES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
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`No
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
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`2. Is this drug product or indication a DESI upgrade?
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` YES
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`NO
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`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
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`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen
`or coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate)
`has not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
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` YES
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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`Reference ID: 3124530
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`Page 2
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`NDA#
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`NDA#
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`NDA#
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`2. Combination product.
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`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing any one of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
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`YES
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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`NDA# 20121
`NDA# 20114
`NDA# 21433
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`Flonase
`Astelin
`Flovent HFA
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`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
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`PART III
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of new
`clinical investigations (other than bioavailability studies) essential to the approval of the application
`and conducted or sponsored by the applicant." This section should be completed only if the answer
`to PART II, Question 1 or 2 was "yes."
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`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
`the application contains clinical investigations only by virtue of a right of reference to clinical
`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
`is "yes" for any investigation referred to in another application, do not complete remainder of
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`Reference ID: 3124530
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`Page 3
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`summary for that investigation.
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`YES
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`NO
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`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
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`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
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`(a) In light of previously approved applications, is a clinical investigation (either conducted
`by the applicant or available from some other source, including the published literature)
`necessary to support approval of the application or supplement?
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` YES
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`NO
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`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
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`(b) Did the applicant submit a list of published studies relevant to the safety and
`effectiveness of this drug product and a statement that the publicly available data would not
`independently support approval of the application?
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`NO
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` YES
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`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
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` YES
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`NO
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` If yes, explain:
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`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
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` YES
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`NO
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` If yes, explain:
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`Reference ID: 3124530
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`Page 4
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`(c)
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`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical
`investigations submitted in the application that are essential to the approval:
`
`Clinical Trial #1: MP4002
`Clinical Trial #2: MP4004
`Clinical Trial #3: MP4006
`Clinical Trial #4: MP4000
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
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`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
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`Investigation #1
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`Investigation #2
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`Investigation #3
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`Investigation #4
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`YES
`
`YES
`
`YES
`
`YES
`
`
`
`
`
`
`
`
`
`NO
`
`NO
`
`NO
`
`NO
`
`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
`
`Investigation #1
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`Reference ID: 3124530
`
`
`Page 5
`
`

`

`Investigation #2
`
`Investigation #3
`
`Investigation #4
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`YES
`
`YES
`
`
`
`
`
`
`
`NO
`
`NO
`
`NO
`
`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
`
`Clinical Trial #1: MP4002
`Clinical Trial #2: MP4004
`Clinical Trial #3: MP4006
`Clinical Trial #4: MP4000
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
`the applicant if, before or during the conduct of the investigation, 1) the applicant was the sponsor of
`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
`providing 50 percent or more of the cost of the study.
`
`a) For each investigation identified in response to question 3(c): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`Investigation #1
`
`
`
`IND # 77363
`
`
`
`
`
`
`YES
`
`
`Investigation #2
`
`
`
`IND # 77363
`
`
`
`
`YES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3124530
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`
`!
`!
`! NO
`! Explain:
`
`Page 6
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3124530
`
`
`
`
`
`Investigation #3
`
`
`
`
`IND # 77363
`
`
`
`
`YES
`
`
`Investigation #4
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`!
`!
`! NO
`! Explain:
`
`!
`!
`! NO
`! Explain:
`conducted outside U.S. (not under IND)
`
`(b) For each investigation not carried out under an IND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
`
`Investigation #1
`
`YES
`
`Explain:
`
`
`
`
`
`Investigation #2
`
`YES
`
`Explain:
`
`
`
`
`
`Investigation #3
`
`YES
`
`Explain:
`
`
`
`
`
`Investigation #4
`
`YES
`
`Explain:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`!
`!
`! NO
`! Explain:
`
`
`
`!
`!
`! NO
`! Explain:
`
`
`
`!
`!
`! NO
`! Explain:
`
`
`
`!
`!
`! NO
`! Explain:
`
`
`
`Page 7
`
`
`
`
`
`
`
`

`

`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
`
`
`
`
`
`YES
`
`
`
`NO
`
`If yes, explain:
`
`=================================================================
`
`Name of person completing form: Philantha Montgomery Bowen, MPH
`Title: Sr. Regulatory Management Officer
`Date: April 11, 2012
`
`Name of Office/Division Director signing form: Badrul A. Chowdhury, MD, PhD
`Title: Division Director
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05
`
`
`Reference ID: 3124530
`
`
`Page 8
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`COLETTE C JACKSON
`05/01/2012
`
`BADRUL A CHOWDHURY
`05/01/2012
`
`Reference ID: 3124530
`
`

`

`l.3. Administrative Information
`
`3.
`
`DEBARMENT CERTIFICATION
`
`Meda Pharmaceuticals Inc. hereby certifies that it did not and will not use in any capacity the
`services ol’any person debarred under section 306 of the Federal Food, Drug, and Cosmetic Act
`in connection with this application.
`
`4/ fl
`
`/ WM,
`
`Veronica Donner
`Meda Pharmaceuticals Inc.
`
`Manager, Corporate Quality Assurance
`
`I‘ll/”#24 2m
`
`Date
`
`Reference ID: 3127881
`Reference ID: 3127881
`
`

`

`ACTION PACKAGE CHECKLIST
`
`NDA # 202236
`
`NDA Supplement #
`BLA Supplement #
`
`Dymista
`Proprietary Name:
`.
`.
`_
`.
`Estabhshed/Proper Name. azelastme and fluttcasone
`Dosage Form:
`nasal spray
`RPM: Philantha Bowen
`
`_
`IfNDA, Efficacy Supplement Type.
`
`.
`.
`Apphcant: Meda Pharmaceuticals
`Agent for Applicant (if applicable):
`
`Division: DPARP
`
`NDAs and NDA Efficag Supplements:
`
`505
`
`2 Ori ' al NDAs and 505
`
`2 NDA su
`
`lements:
`
`NDA Application Type: D 505(b)(1) E 505(b)(2) Listed drug(s) relied upon for approval (include NDA #(s) and drug
`Efficacy Supplement: D 505(b)(1) D 505(b)(2)
`name(s)):
`
`(A supplement can be either a (b)(l) or a (b)(2)
`regardless of whether the original NDA was a (b)(l)
`or a (b)(2). Consult page 1 of the 505(b)(2)
`
`NDA 20121 _ Flonase
`Provide a brief explanation of how this product is difl'erent from the listed
`drug.
`
`
`
`22:33:? or the Appendix to tlns Action Package
`
`New combination nasal spray
`D This application does not reply upon a listed drug.
`I] This application relies on literature.
`I] This application relies on a final OTC monograph.
`D This application relies on (explain)
`
`For ALL b 2 a
`
`lications two months
`
`rior to EVERY action
`
`review the information in the 50512112] Assessment and submit the
`draft2 to CDER 0ND 10 for clearance. Finalize the 505(b)(2)
`Assessment at the time of the approval action.
`
`On the day of amrovaL check the Orange Book again for any new
`patents or pediatric exclusivity.
`
`E No changes
`
`[I Updated Date of check: May 1, 2012
`
`If pediatric exclusivity has been granted or the pediatric information in
`the labeling of the listed drug changed, determine Whether pediatric
`information needs to be added to or deleted from the labeling of this
`drug.
`
`0
`°.° Actions
`
`Proposed action
`0
`0 User Fee Goal Date is May 1, 2012
`
`0
`
`Previous actions (specifv type and datefor each action taken)
`
`1 The Application Information Section is (only) a checklist. The Contents of Action Package Section (beginning on page 5) lists
`the documents to be included in the Action Package.
`2 For resubmissions. (b)(2) applications must be cleared before the action, but it is not necessary to resubmit the draft 505(b)(2)
`Assessment to CDER 0ND IO unless the Assessment has been substantively revised (e.g., nrew listed drug. patent certification
`revised).
`
`Version: 1/27/12
`
`Reference ID: 31 24552
`
`

`

`NDA 202236
`
`Page 2
`
`'3'
`
`Ifaccelerated approval or approval based on efficacy studies in animals, were promotional
`materials received?
`
`Note: Promotional materials to be used within 120 days after approval must have been
`submitted (for exceptions, see
`llflQZ/NHNW fda. gov/downloads/Drugs/GuidanceComplianceRegulatogInfonnation/Guida
`nces/uc111069965.
`. Ifnot submitted. e «lain
`
`D Received
`
`O
`9..
`
`Application Characteristics 3
`
`|Z| Standard El Priority
`Review priority:
`Chemical classification (new NDAs only):
`4
`
`
`
`E] Fast Track
`El Rolling Review
`El Orphan drug designation
`
`I] Rx-to—OTC full switch
`I] Rx—to-OTC partial switch
`El Direct-to-OTC
`
`NDAs: Subpart H
`[I Accelerated approval (21 CFR 314.510)
`E Restricted distribution (21 CFR 314.520)
`Subpart 1
`D Approval based on animal studies
`
`BLAs: Subpart E
`El Accelerated approval (21 CFR 601.41)
`E] Restricted distribution (21 CFR 601.42)
`SubpartH
`D Approval based on animal studies
`
`[I Submitted in response to a PIVIR
`[I Submitted in response to a PMC
`E] Submitted in response to a Pediatric Written Request
`
`Comments:
`
`REMS: D MedGuide
`D Communication Plan
`I] ETASU
`El MedGuide w/o REMS
`E] REMS not required
`
`'1' BLAs only: Ensure RMS-BLA Product Information Sheetfor TBP and RMS—BLA Facility
`Information Sheetfor TBP have been completed and forwarded to OPI/OBI/DRM (Vicky
`Carter
`
`E] Yes, dates
`
`‘6 BLAs only: Is the product subject to ofiic1al FDA lot release per 21 CFR 610.2
`(approvals only)
`
`4° Public communications (approvals only)
`
`0 Office of Executive Programs (OEP) liaison has been notified of action
`
`0
`
`Press Office notified of action (by OEP)
`
`-
`
`Indicate what types (if any) of information dissemination are anticipated
`
`D Yes E No
`
`
`
`FDA Talk Paper
`CDER Q&As
`Other
`
`3 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA
`supplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA. For
`example, if the application is a pending BLA supplement, then a new RMS—BLA Product Information Sheetfor TBP must be
`completed.
`
`Version: 1/27/12
`
`Reference ID: 3124552
`
`

`

`NDA 202236
`
`Page 3
`
`O
`°.° Exclusivity
`
`0
`
`Is approval of this application blocked by any type of exclusivity?
`
`E No
`
`D Yes
`
`0 NDAs and BLAs: Is there existing orphan drug exclusivity for the “same”
`drug or biologic for the proposed indication(s)? Refer to 21 CFR
`31 6.3(b)(13) for the definition of "same drug"for an orphan drug (i.e.,
`active moiety). This definition is NOT the same as that usedfor NDA
`chemical classification.
`
`O
`
`(b)(2) NDAs only: Is there remaining 5-year exclusivity that would bar
`efiecfive approval of a 505 (b)(2) application)? (Note that, even ifexclusirity
`remains, the application may be tentatively approved ifit is othenvise ready
`for approval.)
`
`
`o
`
`(b)(2) NDAs only: Is there remaining 3—year exclusivity that would bar
`efl'ective approval of a 505(b)(2) application? (Note that, even ifexclusivity
`remains, the application may be tentatively approved ifit is otherwise ready
`for approval.)
`
`o
`
`(b)(2) NDAs only: Is there remaining 6—month pediatric exclusivity that
`would bar effective approval of a 505(b)(2) application? (Note that, even if
`exclusivity remains, the application may be tentatively approved ifit is
`otherwise readyfor approval.)
`
`D Yes
`E No
`If, yes, NDA/BLA #
`date exclusivity expires:
`
`and
`
`El Yes
`ENG
`If yes, NDA #
`and date
`exclusivity expires:
`
`D Yes
`BNO
`If yes, NDA #
`and date
`exclusivity expires:
`
`D Yes
`ENO
`If yes, NDA #
`and date
`exclusivity expires:
`
`D Yes
`o NDAs only: Is this a single enantiomer that falls under the 10-year approval E No
`limi''tation of 505(u)? (Note that, even ifthe 10-year approval limitation
`.
`_
`.
`_
`_
`_
`_
`,
`Ifyes, NDA #
`and date 10-
`-
`period has not expired, the application may be tentatively approved ifIt Is
`-
`-
`-
`_
`year limitation expires.
`_
`.
`.
`.
`'
`otherwise I eadyfo: app! owl.)
`
`IXI Verified
`D Not applicable because drug is
`an old antibiotic.
`
`21 CFR 314.50(i)(1)(i)(A)
`E Verified
`
`21 CFR 314.50(i)(1)
`
`X No paragraph III cei1ification
`Date patent will expire
`
`4° Patent Information (NDAs only)
`
`0
`
`Patent Information:
`
`Verify that form FDA-3 542a was submitted for patents that claim the drug for
`which approval is sought.
`If the drug is an old antibiotic, skip the Patent
`
`Certification questions.
`
`0
`
`Patent Certification [505(b)(2) applications]:
`Verify that a certification was submitted for each patent for the listed drug(s) in
`the Orange Book and identify the type of certification submitted for each patent.
`
` O
`
`[505(b)(2) applications] If the application includes a paragraph 111 certification,
`it cannot be approved until the date that the patent to which the certification
`pertains expires (but may be tentatively approved if it is otherwise ready for
`approval).
`
`
`
`
`
`o
`
`[505(b)(2) applications] For each paragraph IV certification, verify that the
`applicant notified the NDA holder and patent owner(s) of its certification that the E N/A (no paragraph Iv ccr