CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`022501Orig1s000
`
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`PATENT INFORMATION SUBMITTED WITH THE
`
`FILING OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and
`Composition) and/or Method of Use
`
`Form APPTOVW: OMB? NO- 0910‘0513
`EXp'rat'O” Date' 04/30/10
`See OMB Statement on Page 3.
`NDA NUMBER
`22.50]
`
`NAME OF {\PF’UCANT’ NDA HOLDER
`Warner Ch'1C0‘tC0mPany' 1““
`
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`TRADE NAME(£§)(§ PROPOSED TRADE NAME)
`
`
`ACTIVE |NGRED|ENT(S)
`Norethindrone acetate / ethinyl estradiol
`
`STRENGTH(S)
`1 mg / 10mcg
`
`
`DOSAGE FORM
`Oral Tablet
`
`required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`This patent declaration form is
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)( ).
`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: If 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 file 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
`
`
`
`
`b.
`
`Issue Date of Patent
`9/3/1996
`
`c. Expiration Date of Patent
`7/22/2014
`
`
`
`a. United States Patent Number
`5.552.394
`
`d. Name of Patent Owner
`Warner Chilcott Company, Inc.
`
`Address (of Patent Owner)
`Union Street. Road 195. km I.I
`
`
`City/State
`Fajardo, Puerto Rico
`
`FAX Number (if available)
`ZIP Code
`00738
`(787) 863-5355
`
`E-Mail Address (if available)
`Telephone Number
`(787) 863-1850
`e. Name of agent or representative who resides or maintains
`Address (of agent or representative named in 1.e.)
`a place of business within the United States authorized to
`100 Enterprise Drive
`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 business within the United States)
`
`City/State
`Rockaway. New Jersey
`
`
`‘7’ Warner Chilcott (US). LLC
`
`ZIP Code
`07866
`
`FAX Number (if available)
`(973) 442.3280
`
`E-Mail Address (if available)
`Telephone Number
`
`(973) 442.3200 ahoward@wcrx.com
`
`f.
`
`9.
`
`Is the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`If the patent referenced above has been submitted previously for listing, is the expiration
`date a new expiration date?
`
`FORM FDA 3542a (7/07)
`
`D Yes
`
`'2 N0
`
`[:I Yes
`
`X No
`
`Page 1
`PS(' Gniplucs. [ml 1 4414090
`EF
`
`(b) (4)
`
`

`

`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.
`
`2. Drug Substance (Active Ingredient)
`
`
`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?
`
`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?
`
`2.3 If the answer to question 2.2 is "Yes," do you certify that, as ofthe date of this declaration, you have test data
`demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NDA? The type of test data required is described at 21 CFR 314.53(b).
`Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`
`
`
`
`Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`Does the patent claim only an intermediate?
`
`
`
`If the patent referenced in 2.1 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.)
`
`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?
`3.2 Does the patent claim only an intermediate?
`
`
`lf 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.)
`
`4. Method of Use
`
`
`IX Yes
`
`E] No
`
`
`
`Sponsors must submit the information in section 4 for each method of using the pending drug product for which approval is being sought
`that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`
`the pending NDA, amendment, or supplement?
`4.2 Patent Claim Number(s) (as listed in the patent)
`Claims I. 7 to l2 (the following information applies
`to each claim)
`4.2a if the answer to 4.2 is
`"Yes," identify YV'th speci-
`ficuty the use With refer-
`ence to the proposed
`labeling for the drug
`product.
`
`Does (Do) the patent claim(s) referenced in 4.2 claim a
`pending method of use for which approval is being sought
`D No
`Q Yes
`in the pending NDA, amendment, or supplement?
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`(b) (4)is indicated for the prevention of pregnancy in women
`(b) (4)
`
`(b) (4)
`
`5. No Relevant Patents
`
`For this pending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and with respect to
`_
`which 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.
`
`FORM FDA 3542a (7/07)
`
`D
`
`Yes
`
`Page 2
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`6. Declaration Certification
`
`6.1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA,
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent information is submitted pursuant to 21 CFR 314.53. I attest that I am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing
`is true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`other Authorized Official) (Provide Information below)
`
`Date Signed
`
`Wk
`
`
`
`3\D‘K\Qfi
`
`information unless it displays a currently valid OMB control number.
`
`NOTE: Only an NDA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant!
`
`holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`Check applicable box and provide information below.
`
`El NDA Applicant/Holder
`
`NDA Applicant’s/Holder’s Attorney, Agent (Representative) or other
`Authorized Official
`
`D Patent Owner
`
`Name
`
`[:I Patent Owner’s Attorney, Agent (Representative) or Other Authorized
`Official
`
`Alvin Howard. Senior Vice President, Regulatory Affairs,»Warner Chilcott (US), LLC
`
`Address
`[00 Enterprise Drive
`
`ZIP Code
`07866
`
`FAX Number (if available)
`(973) 442-3280
`
`City/State
`Rockaway. New Jersey
`
`
`Telephone Number
`(973) 442-3233
`
`E-Mail Address (if available)
`ahoward@wcrx.com
`
`
`
`
`The public reporting burden for this collection of information has been estimated to average 20 hours per response, including the time for reviewing instructions.
`searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this
`burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Food and Dmg Administration
`CDER (HFD-007)
`5600 Fishers Lane
`Rockville, MD 20857
`
`A n agency may not conduct or sponsor. and a person is not required to respond to. a collection of
`
`FORM FDA 3542a (7/07)
`
`Page 3
`
`

`

`EXCLUSIVITY SUMMARY
`
`
`NDA # 022501
`
`
`
`
`
`SUPPL # 000
`
`
`
`HFD # 580
`
`Trade Name: Lo Loestrin Fe
`
`Generic Name: norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and
`ferrous fumarate tablets
`
`
`
`
`
`Applicant Name : Warner Chilcott Company, Inc
`
`Approval Date, If Known: October 21, 2010
`
`PART I
`
`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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`
`
`505(b)(1)
`
`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.")
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`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.
`
`
`
`
`
`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:
`
`
`
`
`
`Page 1
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`d) Did the applicant request exclusivity?
`
`3
`
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`e) Has pediatric exclusivity been granted for this Active Moiety?
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
` 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?
`
`
`
`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
`
`
`2. Is this drug product or indication a DESI upgrade?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`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).
`
`
`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.
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 2
`
`

`

`
`
`
`
`2. Combination product.
`
`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.)
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`**See attached list**
`
`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.
`
`
`PART III
`
`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."
`
`
`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
`summary for that investigation.
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`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,
`
`
`
`
`Page 3
`
`

`

`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.
`
`
`(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?
`
`
` YES
`
`
`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:
`
`
`
`NO
`
`
`
`
`
`(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?
`
`
`(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.
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
` If yes, explain:
`
`(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?
`
`
`
`
`
`
`
` If yes, explain:
`
`
`
`
`
`
`
`
`(c)
`
`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:
`
`Protocol PR-05806
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`
`
`
`
`Page 4
`
`

`

`
`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.")
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`
`
`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?
`
`
`
`
`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`
`NO
`
`
`
`
`
`
`
`
`
`
`
`
`
`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"):
`
`Protocol PR-05806
`
`
`
`
`
`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
`
`
`
`
`Page 5
`
`

`

`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?
`
`
`
`
`!
`
`
`
`
`
`IND # 073510
`
`
`
`
`
`
`
`
`YES
`
`
`
`
`
`
`
`
`
`
`
`
`(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
`
`
`
`
`!
`
`! NO
`! Explain:
`
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`Explain:
`
`
`
`Investigation #2
`
`
`YES
`Explain:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(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:
`
`
`
`
`
`=================================================================
`
`
`
`
`
`Page 6
`
`

`

`Name of person completing form: Karl Stiller, R.Ph.
`Title: Regulatory Health Project Manager
`Date: October 15, 2010
`
`
`Name of Office/Division Director signing form: Scott Monroe, M.D.
`Title: Director, Division of Reproductive and Urologic Products
`
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05
`
`
`
`
`Page 7
`
`

`

`
`List of approved drug product(s) containing the active moiety from Section II, question 2.
`
`
`N016659
`N016954
`N017060
`N017354
`N017355
`N017565
`N017565
`N017576
`N017716
`N017735
`N017743
`N017875
`N017876
`N017919
`N018405
`N018977
`N018985
`N020130
`N020870
`N020870
`N020907
`N020907
`N021065
`N021065
`N021490
`N021871
`N020071
`N021090
`N020301
`N020713
`N021676
`N021098
`N022532
`N021187
`N022262
`N021840
`N021544
`N021864
`N018782
`N021180
`N021490
`N017565
`
`NORINYL 1+50 28-DAY
`MICRONOR
`NOR-QD
`LOESTRIN FE 1/20
`LOESTRIN FE 1.5/30
`NORINYL 1+35 21-DAY
`NORINYL 1+35 28-DAY
`OVCON-50
`OVCON-35
`MODICON 28
`BREVICON 28-DAY
`LOESTRIN 21 1.5/30
`LOESTRIN 21 1/20
`ORTHO-NOVUM 1/35-28
`AYGESTIN
`TRI-NORINYL 28-DAY
`ORTHO-NOVUM 7/7/7-28
`ESTROSTEP FE
`COMBIPATCH
`COMBIPATCH
`ACTIVELLA
`ACTIVELLA
`FEMHRT
`FEMHRT
`FEMCON FE
`LOESTRIN 24 FE
`DESOGEN
`CYCLESSA
`ORTHO-CEPT
`MIRCETTE
`YAZ
`YASMIN
`BEYAZ
`NUVARING
`LOSEASONIQUE
`SEASONIQUE
`SEASONALE
`LYBREL
`NORDETTE-28
`ORTHO EVRA
`FEMCON FE
`NORINYL 1+35 21-DAY
`
`
`
`
`Page 8
`
`

`

`N018985
`N017735
`N017919
`N017716
`N017576
`N018977
`N017743
`N017565
`N021065
`N021065
`N021871
`N017876
`N017875
`N020130
`N017354
`N017355
`N021241
`N019697
`N019653
`N017802
`
`
`
`ORTHO-NOVUM 7/7/7-28
`MODICON 28
`ORTHO-NOVUM 1/35-28
`OVCON-35
`OVCON-50
`TRI-NORINYL 28-DAY
`BREVICON 28-DAY
`NORINYL 1+35 28-DAY
`FEMHRT
`FEMHRT
`LOESTRIN 24 FE
`LOESTRIN 21 1/20
`LOESTRIN 21 1.5/30
`ESTROSTEP FE
`LOESTRIN FE 1/20
`LOESTRIN FE 1.5/30
`ORTHO TRI-CYCLEN LO
`ORTHO TRI-CYCLEN
`ORTHO CYCLEN-28
`LO/OVRAL-28
`
`
`
`
`Page 9
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`KARL J STILLER
`10/21/2010
`
`SCOTT E MONROE
`10/21/2010
`
`Reference ID: 2853079
`
`

`

`Stiller, Karl
`
`
`Trom:
`Sent:
`To:
`Cc:
`Subject:
`
`
`Greeley, George
`
`
`
`
`
`Tuesday, January 19, 2010 10:00 AM
`
`Stiller, Karl
`Stowe, Ginneh D.
`
`
`
`
`NDA 22-501
`
`(‘3) (4)
`
`Importance:
`
`High
`
`
`
`Follow Up Flag:
`Flag Status:
`
`
`
`Follow up
`Yellow
`
`
`Hi Karl,
`
`
`
`
`
`
`
`
`
`
`
`
`The
`(W4) (norethrine acetate and ethinyl estradiol) partial waiver and extrapolation was
`
`
`
`
`
`
`
`
`
`
`
`
`reviewed by the PeRC PREA Subcommittee on November 04, 2009. The Division recommended a
`
`
`
`
`
`
`
`
`
`
`
`partial waiver because studies would be impossible or highly impracticable because the
`
`
`
`
`
`disease / condition does not exist in children.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`The PeRC agreed with the Division to grant a partial waiver for this product and that the
`
`
`
`
`
`
`
`
`
`
`
`
`
`extrapolation of efficacy will occur for pediatric patients 12 years of age and older.
`
`Thank you.
`
`
`
`George Greeley
`
`
`
`Regulatory Health Project Manager
`
`
`
`
`Pediatric and Maternal Health Staff
`
`
`
`Office of New Drugs
`FDA/ CDER
`
`
`
`10903 New Hampshire Ave.
`
`
`
`Bldg #22, Room 6467 . ~ .
`
`
`
`Silver Spring, MD 20993- 0002
`301. 796. 4025
`
`C? Please consider the environment before printing this email.
`
`
`
`
`
`
`
`
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`WARNER CHILCOTT
`
`
`1.3. Administrative Information
`
`3.
`
`
`
`DEBARMENT CERTIFICATION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I hereby certify that Warner Chilcott Company, Inc. did not and will not use in any capacity the
`
`
`
`
`services of any person debarred under section 306(a) and (b) of the Federal Food, Drug and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cosmetic Act in connection with this New Drug Application.
`
`W '
`
`eke-M:
`
`
`
`
`Alvin Howard
`
`
`
`
`Senior Vice President, Regulatory Affairs
`
`
`
`
`
`
`Warner Chilcott (US), LLC on behalf of
`
`
`
`Warner Chilcott Company, Inc.
`
`.
`
`Date
`
`
`
`CONFIDENTIAL
`
`

`

`
`
`
`
`Proprietary Name: Lo Loestrin Fe
`Established/Proper Name: norethindrone acetate (NA) and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ethinyl estradiol (EE) 1 mg NA/ 10 mcg EB, 10 mcg EE,
`
`
`Dosa_e Form:
`tablet
`RPM: Karl Stiller
`
`
`
`
`NDAs:
`
`
`
`NDA Application Type: E 505(b)(1)
`
`
`Efficacy Supplement:
`E] 505(b)(1)
`
`
`
`
`
`
`
`
`
`
`
`ACTION PACKAGE CHECKLIST
`
`
`
`24w vs
`low .a
`NDA Supplement #
`.
`.
`
`
`
`
`BLA STN #
`If NDA, Efficacy Supplement Type. Orlg
`
`NDA # 22501
`BLA #
`
`
`
`
`
`
`
`
`
`
` Applicant: Warner Chilcott Company, Inc.
`Agent for Applicant (if applicable):
`
`
`
`
`
`
`
`
`
`
`Division: DRUP
`
`
`
`
`
`
`
`
`5051sz 2! Original NDAs and 505(b)(21NDA supplements:
`
`
`
`
`
`
`
`
`
`
`
`505(b)(2) Listed drug(s) relied upon for approval (include NDA #(s) and drug
`
`
`505(b)(2)
`name(s)):
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Provide a brief explanation of how this product is different from the listed
`
`
`drug.
`
`
`
`
`
`
`
` If no listed drug, explain.
`
`
`E] This application relies on literature.
`
`
`
`
`
`D This application relies on a final OTC monograph.
`
`
`
`
`
`
`
`
`
`D Other (explain)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Two months prior to each action, review the information in the
`
`
`
`
`
`
`
`
`
`
`505(b)(2) Assessment and submit the draft to CDER 0ND 10 for
`
`
`clearance. Finalize the 505(b)(2) Assessment at the time of the
`
`
`
`
`
`
`
`
`
`approval action.
` On} the day of ap‘proval, check the Orange Book again for any new
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`patents or pediatric exclusivity.
`E] No changes D Updated Date of check:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`(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)
`
`
`
`
`
`
`
`
`
`
`
`Assessment or the Appendix to this Action Package
`Checklist.)
`
`
`
`
`
`
`
`Proposed action
`
`
`
`
`
`User Fee Goal Date is October 21 2010
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Previous actions (specify 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.
`
`Version: 8/25/10
`
`
`
`

`

`I N
`
`DA/BLA #
`
`Page 2
`
`
`'3?
`
`If accelerated 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
`hmzflwww.fda.gov/downloads/Drugs/GuidanceComplianceRegulatogglnformation/Guida
`
`
`
`
`. If not submitted, ex-lain
`nces/ucm069965.
`_
`
`U Received
`
`
`'3 Application Characteristics 2
`
`
`
`
`
`
`
`
`[3 Priority
`Review priority: 8 Standard
`
`
`
`
`Chemical classification (new NDAs only):
`
`
`
`[3 Fast Track
`
`D Rolling Review
`
`
`D Orphan drug designation
`
`
`
`
`I] Rx—to-OTC fidll switch
`
`
`
`a Rx-to-OTC partial switch
`
`
`
`E] Direct-to-OTC
`
`
`
`
`NDAs: Subpart H
`D Accelerated approval (21 CFR 314.510)
`
`
`
`
`
`[:1 Restricted distribution (21 CFR 314.520)
`
`
`
`
`
`
`Subpart I
`-
`D Approval based on animal studies
`
`
`
`
`
`
`
`BLAs: Subpart E
`U Accelerated approval (21 CFR 601.41)
`
`
`
`
`
`El Restricted distribution (21 CFR 601.42)
`
`
`
`
`
`Subpart H
`E] Approval based on animal studies
`
`
`
`
`
`'
`
`Submitted in response to a PMC
`
`
`
`
`
`
`I Submitted in response to a Pediatric Written Request
`
`
`
`
`
`
`
`
`
`Submitted in response to a PMR
`
`
`
`
`REMS: E] MedGuide
`8 Communication Plan
`ETASU
`
`
`U REMS not required
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Comments: On January 26, 2010, this application received a CR letter due to deficiencies at a drug substance
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`manufacturing facility and a control testing laboratory which resulted in an overall "withold" recommendation from the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Office of Compliance. The previously idendified deficiencies were corrected and on April 21, 201, the Applicant submitted
`a Class 2 Resubmission.
`
`
`
`‘
`'4" . 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)
`.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cl Other
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Indicate what types (if any) of information dissemination are anticipated
`
`
`
`
`
`
`
`
`
`
`I: Yes, dates
`
`
`
`_
`
`
`
`
`
`
`
`
`
`
`
`
`
`D HHS Press Release
`
`
`
`FDA Talk Paper
`CDER Q&As
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`'oplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA. For
`.ample, if the application is a pending BLA supplement, then a new RMS-BLA Product Information Sheetfor TBP must be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`completed.
`
`Version: 8/25/10
`
`
`

`

`’A,
`
`NDA/BLA #
`
`Page 3
`
`
`“ Exclusivity
`
`
`0
`
`Is approval of this application blocked by any type of exclusivity?
`
`
`
`
`
`
`
`
`
`E No
`
`
`[I 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
`
`
`
`
`
`
`
`
`
`
`
`316.3(b)(13)f0r 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.
`
`
`
`D Yes
`No
`
`
`
`If, yes, NDA/BLA #
`date exclusivity expires:
`
`
`
`and
`
`0
`
`(b)(2) NDAs only: Is there remaining 5—year exclusivity that would bar
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`effective approval of a 505(b)(2) application)? (Note that, even ifexclusivity
`remains, the application may be tentatively approved ifit is otherwise ready
`
`
`
`
`
`
`
`
`
`for approval.)
`
`
`D Yes
`El No
`
`
`If es NDA #
`and date
`
`
`
`
`y ’
`exclusivity expires:
`
`
`
`
`0
`
`(b)(2) NDAs only: Is there remaining 3-year exclusivity that would bar
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`