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`,, ......... ,,,
`( ~ Ii U.S. FOOD & DRUG 'Q ~ ADMINISTRATION
`NDA 218754
`TENTATIVE APPROVAL
`Azurity Pharmaceuticals, Inc.
`Attention: Srinivasa Rao Kodela
`Director, Regulatory Affairs
`8 Cabot Road
`Suite 2000
`Woburn, MA 01801
`Dear Srinivasa Rao Kodela:
`Please refer to your new drug application (NDA) dated September 28, 2023, received
`September 28, 2023, and your amendments, submitted pursuant to section 505(b)(2) of
`the Federal Food, Drug, and Cosmetic Act (FD&C Act) for Aprepitant Injectable
`Emulsion.
`This NDA proposes the use of Aprepitant Injectable Emulsion for the following
`indications:
`(b) (4)
`We have completed our review of this application, as amended. It is tentatively
`approved under 21 CFR 314.105(a); therefore, this application is not approved and will
`not be approved until FDA issues an approval letter after any necessary additional
`review of the application. Enclosed are the tentatively approved labeling (text for the
`Prescribing Information, Patient Package Insert, carton and container labeling). This
`tentative approval determination is based upon information available to the Agency at
`this time, (i.e., information in your application and the status of current good
`manufacturing practices of the facilities used in the manufacture and testing of the drug
`product). This determination is subject to change on the basis of new information that
`may come to our attention.
`Reference ID: 5417239
`Page 1 of 5
`HELSINN EXHIBIT 2008
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00947
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`NDA 218754
`Page 2
`Final approval of your application is subject to expiration of a period of patent protection
`and/or exclusivity. Therefore, final approval of your application may not be granted
`before the period has expired.
`Final approval of your application is subject to expiration of the 30-month period
`provided for in section 505(c)(3)(C) of the FD&C Act. Therefore, final approval of your
`application may not be granted at this time.
`A listed drug(s) upon which your application relies is subject to a period of patent
`protection, and your application contains a certification(s) to one or more patents under
`section 505(b)(2)(A)(iv) of the FD&C Act stating that the patent(s) is/are invalid,
`unenforceable, or will not be infringed by your manufacture, use, or sale of, this drug
`product under this application (“paragraph IV certification”).
`Section 505(c)(3)(C) of the FD&C Act provides that approval of a new drug application
`submitted pursuant to section 505(b)(2) of the FD&C Act that includes a paragraph IV
`certification shall be made effective immediately, unless an action is brought for
`infringement of one or more of the patents that were the subject of a paragraph IV
`certification. If such a patent infringement action is brought prior to the expiration of 45
`days from the later of the date the notice provided under section 505(b)(3) is received
`by the patent owner or approved application holder, then your application would be
`subject to a 30-month stay of approval, unless other conditions are met. You notified us
`that you complied with the requirements of section 505(b)(3) of the FD&C Act.
`In addition, you have notified the Agency that the patent owner and/or approved
`application holder has initiated a patent infringement suit against you with respect to
`U.S. Patent Nos. 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794; 10,500,208;
`10,624,850; 10,953,018; and 11,173,118 in the United States District Court, District of
`New Jersey (Case 2:24-cv-00423). With respect to the patent infringement suit, final
`approval cannot be granted until:
`(1)
`• expiration of the 30-month period provided for in section 505(c)(3)(C)
`beginning on the later of the date of receipt by any owner of the listed patent
`or application holder of the notice required under section 505(b)(3), unless the
`court has extended or reduced the period because of the failure of either
`party to reasonably cooperate in expediting the action, or
`• the date the court decides that the patent(s) is/are invalid or not infringed as
`described in section 505(c)(3)(C)(i), (ii), (iii), or (iv) of the FD&C Act, or,
`• the date the court disposes of the patent litigation as described in 21 CFR
`314.107(b)(3)(viii),
`• the listed patent(s) has/have expired, and
`(2) we are assured there is no new information that would affect whether final
`approval should be granted.
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`Reference ID: 5417239
`Page 2 of 5
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`NDA 218754
`Page 3
`To obtain final approval of this application, submit an amendment two or six months
`prior to the date you believe that your NDA will be eligible for final approval, as
`appropriate. In your cover letter, clearly identify your amendment as “REQUEST FOR
`FINAL APPROVAL”. This amendment should provide the legal/regulatory basis for
`your request for final approval and should include a copy of any relevant court order or
`judgment settlement, or licensing agreement, as appropriate. In addition to a safety
`update, the amendment should also identify changes, if any, in the conditions under
`which your product was tentatively approved, i.e., updated labeling; chemistry,
`manufacturing, and controls data; and risk evaluation and mitigation strategy (REMS). If
`there are no changes, clearly state so in your cover letter. Any changes require our
`review before final approval and the goal date for our review will be set accordingly.
`Until we issue a final approval letter, this NDA is not approved, and cannot be legally
`marketed and the use of the enclosed tentatively approved labeling is not permitted for
`marketing this drug product. If you believe that there are grounds for issuing the final
`approval letter before the expiration of the patent(s), you should amend your application
`accordingly.
`PROPRIETARY NAME
`If you intend to have a proprietary name for this product, the name and its use in the
`labeling must conform to the specifications under 21 CFR 201.10 and 201.15. We
`recommend that you submit a request for a proposed proprietary name review. (See the
`guidance for industry Contents of a Complete Submission for the Evaluation of
`Proprietary Names (April 2016)
`1, guidance for industry Best Practices in Developing
`Proprietary Names for Human Prescription Drug Products (December 2020), and
`PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through
`2027.)2
`THERAPEUTIC EQUIVALENCE EVALUATION REQUEST
`Your submission includes a Therapeutic Equivalence Evaluation Request (TEER)
`submitted pursuant to section 505(j)(7)(A)(v)(I)(aa) of the FD&C Act. Section
`505(j)(7)(A) of the FD&C Act was amended by section 3222 of the Food and Drug
`Omnibus Reform Act of 2022 (FDORA, enacted December 29, 2022) and, as amended
`sets forth certain conditions under which FDA evaluates whether an eligible drug
`submitted in an application pursuant to section 505(b)(2) of the FD&C Act is
`therapeutically equivalent (TE) to a listed drug relied upon in the 505(b)(2) application.
`This provision provides that evaluation of requests that meet applicable requirements
`1 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`2 https://www.fda.gov/media/151712/download
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`Reference ID: 5417239
`Page 3 of 5
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`NDA 218754
`Page 4
`will be made at the time of approval or not later than 180 days after the date of approval
`of such application.
`Neither this letter, nor the tentative approval of your application constitutes a
`determination that your request meets applicable requirements under section
`505(j)(7)(A)(v)(I)(aa) of the FD&C Act.
`If you have any questions, contact Mary Chung, Regulatory Project Manager, at (301)
`796-0260 or Mary.Chung@fda.hhs.gov.
`Sincerely,
`{See appended electronic signature page}
`Erica Lyons, M.D.
`Associate Director for Therapeutic Review
`Division of Gastroenterology
`Office of Immunology and Inflammation
`Office of New Drugs
`Center for Drug Evaluation and Research
`ENCLOSURE(S): (tentatively approved)
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`o Carton and Container Labeling
`31 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS)
`immediately following this page
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`Reference ID: 5417239
`Page 4 of 5
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`(
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`--------------------------------------------------------------------------------------------
`--------------------------------------------------------------------------------------------
`------------------------------------------------------------
`Signature Page 1 of 1
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`/s/
`ERICA M LYONS
`07/25/2024 03:51:35 PM
`Reference ID: 5417239
`Page 5 of 5
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