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`ANDA 210285
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` ANDA TENTATIVE APPROVAL
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` Stason Pharmaceuticals, Inc.
` U.S. Agent for Sawai USA, Inc.
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` 11 Morgan
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` Irvine, CA 92618
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` Attention: Sang Lee
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` Senior Director, Global Development and RA
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` Dear Sir:
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` This letter is in reference to your abbreviated new drug application (ANDA) received for review
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` on March 27, 2017, submitted pursuant to section 505(j) of the Federal Food, Drug, and
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` Cosmetic Act (FD&C Act) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and
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` 240 mg.
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` Reference is also made to the complete response letter issued by this office on
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` November 9, 2018, and to any amendments thereafter.
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` We have completed the review of this ANDA, and have concluded that adequate information
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` in the submitted labeling. The Office of Bioequivalence has determined your Dimethyl Fumarate
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` Delayed-Release Capsules, 120 mg and 240 mg, to be bioequivalent and, therefore,
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` therapeutically equivalent to the reference listed drug (RLD), Tecfidera Delayed-Release
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` Capsules, 120 mg and 240 mg, of Biogen, Inc. (Biogen).
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` However, we are unable to grant final approval to your ANDA at this time because of the patent
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` issue noted below. Therefore, the ANDA is tentatively approved. This determination is based
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` upon information available to the Agency at this time (e.g., information in your ANDA and the
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` status of current good manufacturing practices (cGMPs) of the facilities used in the
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` manufacturing and testing of the drug product). This determination is subject to change on the
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` basis of new information that may come to our attention. This letter does not address issues
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` related to the 180-day exclusivity provisions under section 505(j)(5)(B)(iv) of the FD&C Act.
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` The RLD upon which you have based your ANDA, Biogen's Tecfidera Delayed-Release
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` Capsules, 120 mg and 240 mg, is subject to periods of patent protection. The following patents
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` Products with Therapeutic Equivalence Evaluations (the “Orange Book”):
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` U.S. Patent Number
` Expiration Date
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` 6,509,376 (the '376 patent)
` April 1, 2019
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` 7,320,999 (the '999 patent)
` October 20, 2019
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` U.S. Food & Drug Administration
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` 10903 New Hampshire Avenue
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` Silver Spring, MD 20993
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` www.fda.gov
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`Biogen Exhibit 2007
`Sawai v. Biogen
`IPR2019-00789
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`Page 1 of 5
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` ANDA 210285
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` 7,619,001 (the '001 patent)
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` 7,803,840 (the '840 patent)
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` 8,399,514 (the '514 patent)
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` June 20, 2020
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` April 1, 2019
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` February 7, 2028
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` Your ANDA contains paragraph IV certifications to each of the patents under section
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` 505(j)(2)(A)(vii)(IV) of the FD&C Act stating that the patents are invalid, unenforceable, or will
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` not be infringed by your manufacture, use, or sale of Dimethyl Fumarate Delayed-Release
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` Capsules, 120 mg and 240 mg, under this ANDA. You have notified the Agency that Sawai
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` USA, Inc. (Sawai) complied with the requirements of section 505(j)(2)(B) of the FD&C Act, and
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` litigation was initiated within the statutory 45-day period against Sawai for infringement of the
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` '376, '999, '001, '840, and '514 patents in the United States District Court for the District of
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` Delaware [Biogen International GmbH and Biogen MA Inc. v. Sawai USA, Inc. and Sawai
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` Pharmaceutical Co., Ltd., Civil Action No. 17-00875].
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` Therefore, final approval cannot be granted until:
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`1. a.
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` the expiration of the 7.5-year period provided for in sections 505(j)(5)(B)(iii) and
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` 505(j)(5)(F)(ii) of the FD&C Act,
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` the date the court decides1 that the '376, '999, '001, '840, and '514 patents are
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` invalid or not infringed (see sections 505(j)(5)(B)(iii)(I), (II), and (III) of the FD&C
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` Act), or
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` the '376, '999, '001, '840, and '514 patent have expired, and
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`c.
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`2. The Agency is assured there is no new information that would affect whether final
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` approval should be granted.
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` Please note that if FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for a listed
` drug, an ANDA citing that listed drug also will be required to have a REMS. See section 505-
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` 1(i) of the FD&C Act.
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` RESUBMISSION
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` To request final approval, please submit an amendment titled “FINAL APPROVAL
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` 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,
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` information, or other changes to the ANDA generally requires a period of 90 days for Agency
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` review. Accordingly, such a request for final approval should be submitted no later than 90 days
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` prior to the date on which you seek approval. A request for final approval that contains
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` substantive changes to this ANDA or changes in the status of the manufacturing and testing
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` facilities’ compliance with cGMPs will be classified and reviewed according to OGD policy in
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` effect at the time of receipt. Applicants should review available agency guidance for industry
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` related to amendments under the generic drug user fee program to determine the duration of
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` Agency review needed to review the changes submitted. The submission of multiple
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` U.S. Food & Drug Administration
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` 10903 New Hampshire Avenue
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` Silver Spring, MD 20993
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` www.fda.gov
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` Page 2 of 4
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`Page 2 of 5
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` ANDA 210285
` Page 3
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` amendments prior to final approval may also result in a delay in the issuance of the final
` approval letter.
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` The amendment requesting final approval should provide the legal/regulatory basis for your
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` 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
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` identify changes, if any, in the conditions under which the ANDA was tentatively approved, e.g.,
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` updated information such as final-printed labeling, chemistry, manufacturing, and controls data
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` as appropriate. This amendment should be submitted even if none of these changes were
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` made, and it should be designated clearly in your cover letter as a “FINAL APPROVAL
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` REQUESTED.”
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` In addition to the amendment requested above, the Agency may request, at any time prior to the
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` date of final approval, that you submit an additional amendment containing information as
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` specified by the Agency. Failure to submit either or, if requested, both types of amendments
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` described above may result in a delay in the issuance of the final approval letter.
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` This drug product may not be marketed without final Agency approval under section 505(j) of
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` the FD&C Act. The introduction or delivery for introduction into interstate commerce of this drug
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` product before the final approval date is prohibited under section 301 of the FD&C Act. Also,
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` until the Agency issues the final approval letter, this drug product will not be deemed approved
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` for marketing under section 505(j) of the FD&C Act and will not be listed in the Orange Book.
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` ANNUAL FACILITY FEES
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` 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
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` annual facility fees. Your ANDA identifies at least one facility that is subject to the self-
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` identification requirement and payment of an annual facility fee. Self-identification must occur
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` by June 1st of each year for the next fiscal year. Facility fees must be paid each year by the
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` date specified in the Federal Register notice announcing facility fee amounts. All finished
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` dosage forms (FDFs) or active pharmaceutical ingredients (APIs) manufactured in a facility that
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` has not met its obligations to self-identify or to pay fees when they are due will be deemed
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` misbranded. This means that it will be a violation of federal law to ship these products in
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` interstate commerce or to import them into the United States. Such violations can result in
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` prosecution of those responsible, injunctions, or seizures of misbranded products. Products
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` misbranded because of failure to self-identify or pay facility fees are subject to being denied
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` entry into the United States.
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` In addition, we note that GDUFA requires that certain non-manufacturing sites and
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` organizations listed in generic drug submissions comply with the self-identification requirement.
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` The failure of any facility, site, or organization to comply with its obligation to self-identify and/or
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` to pay fees when due may raise significant concerns about that site or organization and is a
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` factor that may increase the likelihood of a site inspection prior to approval. FDA does not
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` expect to give priority to completion of inspections that are required simply because facilities,
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` sites, or organizations fail to comply with the law requiring self-identification or fee payment.
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` U.S. Food & Drug Administration
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` 10903 New Hampshire Avenue
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` Silver Spring, MD 20993
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` www.fda.gov
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` Page 3 of 4
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`Page 3 of 5
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` ANDA 210285
` Page 4
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` Additionally, we note that the failure of any facility referenced in the application to self-identify
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` and pay applicable fees means that FDA will not consider the GDUFA application review goal
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` dates to apply to that application.
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` For further information on the status of this ANDA or upon submitting an amendment to the
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` ANDA, please contact Dara Nardini, Regulatory Project Manager, at (240) 402 - 2703.
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` Sincerely yours,
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` {See appended electronic signature page}
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` For Vincent Sansone, PharmD
` Deputy Director
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` Office of Regulatory Operations
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` Office of Generic Drugs
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` Center for Drug Evaluation and Research
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` 1 This decision may be either a decision of the district court or the court of appeals, whichever court is the first to
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` 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
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` Law 115-52, Title III).
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` U.S. Food & Drug Administration
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` 10903 New Hampshire Avenue
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` Silver Spring, MD 20993
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` www.fda.gov
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` Page 4 of 4
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`Page 4 of 5
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`

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`Heidi
`Lee
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`Digitally signed by Heidi Lee
`Date: 3/25/2019 09:28:18AM
`GUID: 52795fe90009070673e7de063d080d1f
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`(
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`Page 5 of 5
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