`
`ANDA 211528
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`
`
`ANDA TENTATIVE APPROVAL
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`
`
`
`Apotex Corp.
`U.S. Agent for Apotex Inc.
`2400 North Commerce Parkway, Suite 400
`Weston, FL 33326
`Attention: Kiran Krishnan
`
` Senior Vice President, Global Regulatory Affairs
`
`
`Dear Sir:
`
`
`This letter is in reference to your abbreviated new drug application (ANDA) received for review
`on January 4, 2018, submitted pursuant to section 505(j) of the Federal Food, Drug, and
`Cosmetic Act (FD&C Act) for Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL.
`
`
`Reference is also made to any amendments submitted prior to the issuance of this letter.
`
`
`We have completed the review of this ANDA and have concluded that adequate information has
`been presented to demonstrate that the drug is safe and effective for over-the-counter (OTC)
`use as recommended in the submitted labeling. The Office of Bioequivalence has determined
`your Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL, to be bioequivalent to the
`reference listed drug (RLD), Xyzal Allergy 24HR Oral Solution, 2.5 mg/5 mL, of Sanofi-Aventis
`U.S. LLC (Sanofi).
`
`
`However, we are unable to grant final approval to your Levocetirizine Dihydrochloride Oral
`Solution, 2.5 mg/5 mL, at this time because of the patent issue noted below. Therefore, your
`ANDA is tentatively approved. This determination is based upon information available to the
`Agency at this time (e.g., information in your ANDA and the status of current good
`manufacturing practices (cGMPs) of the facilities used in the manufacturing and testing of the
`drug product). This determination is subject to change on the basis of new information that may
`come to our attention. This letter does not address issues related to the 180-day exclusivity
`provisions under section 505(j)(5)(B)(iv) of the FD&C Act.
`
`
`The RLD upon which you have based your ANDA, Sanofi's Xyzal Allergy 24HR Oral Solution,
`2.5 mg/5 mL, is subject to a period of patent protection. The following patent and expiration
`date is currently listed in the Agency’s publication titled Approved Drug Products with
`Therapeutic Equivalence Evaluations (the “Orange Book”):
`
`
`
`
`
`
`U.S. Patent Number
`Expiration Date
`
`
`
`
`
`8,633,194 (the '194 patent)
`October 16, 2027
`
`
`
`
`U.S. Food & Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`www.fda.gov
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2007
`Page 1
`
`

`

`ANDA 211528
`Page 2
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`Your ANDA contains a paragraph IV certification to the '194 patent under section
`505(j)(2)(A)(vii)(IV) of the FD&C Act stating that the patent is invalid, unenforceable, or will not
`be infringed by your manufacture, use, or sale of Levocetirizine Dihydrochloride Oral Solution,
`2.5 mg/5 mL, under this ANDA. You have notified the Agency that Apotex Inc. (Apotex)
`complied with the requirements of section 505(j)(2)(B) of the FD&C Act, and litigation was
`initiated within the statutory 45-day period against Apotex for infringement of the '194 patent in
`the United States District Court for the Southern District of Florida [UCB, Inc. and UCB
`Biopharma SPRL v. Apotex Inc., Civil Action No. 18-60846].
`
`Therefore, final approval cannot be granted until:
`
`1. a.
`
`the expiration of the 30-month period provided for in section 505(j)(5)(B)(iii) of the
`FD&C Act,
`
`b.
`
`the date the court decides1 that the '194 patent is invalid or not infringed (see
`sections 505(j)(5)(B)(iii)(I), (II), and (III) of the FD&C Act), or
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`c.
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`the '194 patent has expired, and
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`2. The Agency is assured there is no new information that would affect whether final
`approval should be granted.
`
`RESUBMISSION
`
`To request final approval, please submit an amendment titled “FINAL APPROVAL
`REQUESTED” with enough time to permit FDA review prior to the date you believe that your
`ANDA will be eligible for final approval. A request for final approval that contains no new data,
`information, or other changes to the ANDA generally requires a period of 90 days for Agency
`review. Accordingly, such a request for final approval should be submitted no later than 90 days
`prior to the date on which you seek approval. A request for final approval that contains
`substantive changes to this ANDA or changes in the status of the manufacturing and testing
`facilities’ compliance with cGMPs will be classified and reviewed according to OGD policy in
`effect at the time of receipt. Applicants should review available agency guidance for industry
`related to amendments under the generic drug user fee program to determine the duration of
`Agency review needed to review the changes submitted. The submission of multiple
`amendments prior to final approval may also result in a delay in the issuance of the final
`approval letter.
`
`The amendment requesting final approval should provide the legal/regulatory basis for your
`request for final approval and should include a copy of a court decision, settlement or licensing
`agreement, or other information described in 21 CFR 314.107, as appropriate. It should also
`identify changes, if any, in the conditions under which the ANDA was tentatively approved, e.g.,
`updated information such as final-printed labeling, chemistry, manufacturing, and controls data
`as appropriate. This amendment should be submitted even if none of these changes were
`made, and it should be designated clearly in your cover letter as a “FINAL APPROVAL
`REQUESTED.”
`
`In addition to the amendment requested above, the Agency may request, at any time prior to the
`date of final approval, that you submit an additional amendment containing information as
`
`U.S. Food & Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`www.fda.gov
`
`Page 2 of 4
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2007
`Page 2
`
`

`

`ANDA 211528
`Page 3
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`specified by the Agency. Failure to submit either or, if requested, both types of amendments
`described above may result in a delay in the issuance of the final approval letter.
`
`This drug product may not be marketed without final Agency approval under section 505(j) of
`the FD&C Act. The introduction or delivery for introduction into interstate commerce of this drug
`product before the final approval date is prohibited under section 301 of the FD&C Act. Also,
`until the Agency issues the final approval letter, this drug product will not be deemed approved
`for marketing under section 505(j) of the FD&C Act, and will not be listed in the Orange Book.
`
`ANNUAL FACILITY FEES
`
`The Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III)
`established certain provisions2 with respect to self-identification of facilities and payment of
`annual facility fees. Your ANDA identifies at least one facility that is subject to the
`self-identification requirement and payment of an annual facility fee. Self-identification must
`occur by June 1st of each year for the next fiscal year. Facility fees must be paid each year by
`the date specified in the Federal Register notice announcing facility fee amounts. All finished
`dosage forms (FDFs) or active pharmaceutical ingredients (APIs) manufactured in a facility that
`has not met its obligations to self-identify or to pay fees when they are due will be deemed
`misbranded. This means that it will be a violation of federal law to ship these products in
`interstate commerce or to import them into the United States. Such violations can result in
`prosecution of those responsible, injunctions, or seizures of misbranded products. Products
`misbranded because of failure to self-identify or pay facility fees are subject to being denied
`entry into the United States.
`
`In addition, we note that GDUFA requires that certain non-manufacturing sites and
`organizations listed in generic drug submissions comply with the self-identification requirement.
`The failure of any facility, site, or organization to comply with its obligation to self-identify and/or
`to pay fees when due may raise significant concerns about that site or organization and is a
`factor that may increase the likelihood of a site inspection prior to approval. FDA does not
`expect to give priority to completion of inspections that are required simply because facilities,
`sites, or organizations fail to comply with the law requiring self-identification or fee payment.
`
`Additionally, we note that the failure of any facility referenced in the application to self-identify
`and pay applicable fees means that FDA will not consider the GDUFA application review goal
`dates to apply to that application.
`
`U.S. Food & Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`www.fda.gov
`
`Page 3 of 4
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2007
`Page 3
`
`

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`ANDA 211528
`Page 4
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`For further information on the status of this ANDA or upon submitting an amendment to the
`ANDA, please contact Lauren Moulder, Regulatory Project Manager, at (301) 796 - 0212.
`
`Sincerely yours,
`
`{See appended electronic signature page}
`
`For Vincent Sansone, PharmD
`Deputy Director
`Office of Regulatory Operations
`Office of Generic Drugs
`Center for Drug Evaluation and Research
`
`1 This decision may be either a decision of the district court or the court of appeals, whichever court is the first to
`decide that the patent is invalid or not infringed.
`2 Some of these provisions were amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Public
`Law 115-52, Title III).
`
`U.S. Food & Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`www.fda.gov
`
`Page 4 of 4
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2007
`Page 4
`
`

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`Priya
`Shah
`
`Digitally signed by Priya Shah
`Date: 11/02/2018 04:53:02PM
`GUID: 5256c7080002b0e78814870319c70608
`
`(
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2007
`Page 5
`
`