DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring, MD 20993
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`ANDA APPROVAL
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`ANDA 091646
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`Mylan Pharmaceuticals Inc.
`781 Chestnut Ridge Rd.
`P.O. Box 4310
`Morgantown, WV 26504
`Attention: Wayne Talton
`Head of Global Regulatory Affairs
`
`Dear Sir:
`
`This letter is in reference to your abbreviated new drug application (ANDA) received for review
`on June 29, 2009, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic
`Act (FD&C Act) for Glatiramer Acetate Injection, 20 mg/mL.
`
`Reference is also made to the complete response letter issued by this office on February 28,
`2017, and to any amendments thereafter.
`
`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 use as recommended in the
`submitted labeling. Accordingly, the ANDA is approved, effective on the date of this letter.
`The Office of Bioequivalence has determined your Glatiramer Acetate Injection, 20 mg/mL, to
`be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD),
`Copaxone Injection, 20 mg/mL, of Teva Pharmaceuticals USA.
`
`Under section 506A of FD&C Act, certain changes in the conditions described in this ANDA
`require an approved supplemental application before the change may be made.
`
`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-
`1(i) of the FD&C Act.
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`REPORTING REQUIREMENTS
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`Postmarketing reporting requirements for this ANDA are set forth in 21 CFR 314.80-81 and
`314.98. The Office of Generic Drugs should be advised of any change in the marketing status of
`this drug.
`
`Biogen Exhibit 2162
`Mylan v. Biogen
`IPR 2018-01403
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`Page 1 of 4
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`ANDA 091646
`Page 2
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling materials prior to publication or dissemination. Please note that these submissions are
`voluntary. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`(PI), Medication Guide, and patient PI (as applicable) to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
`
`You must also submit final promotional materials and package insert(s), accompanied by a Form
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf.
`For more information about submission of promotional materials to the Office of Prescription
`Drug Promotion (OPDP), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`ANNUAL FACILITY FEES
`
`The Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III)
`established certain provisions 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.
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`Page 2 of 4
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`ANDA 091646
`Page 3
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling [21 CFR
`314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical in content to the approved labeling (including the package insert, and any patient
`package insert and/or Medication Guide that may be required). Information on submitting SPL
`files using eLIST may be found in the guidance for industry titled “SPL Standard for Content of
`Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. The SPL will be accessible via publicly available labeling repositories.
`
`The Electronic Common Technical Document (eCTD) is CDER’s standard format for electronic
`regulatory submissions. Beginning May 5, 2017, ANDAs must be submitted in eCTD format
`and beginning May 5, 2018, drug master files must be submitted in eCTD format. Submissions
`that do not adhere to the requirements stated in the eCTD Guidance will be subject to rejection.
`For more information please visit: www.fda.gov/ectd.
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`Sincerely yours,
`
`{See appended electronic signature page}
`
`For Vincent Sansone, PharmD
`Acting Deputy Director
`Office of Regulatory Operations
`Office of Generic Drugs
`Center for Drug Evaluation and Research
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`Page 3 of 4
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`Heidi
`Lee
`
`Digitally signed by Heidi Lee
`Date: 10/03/2017 10:45:45AM
`GUID: 52795fe90009070673e7de063d080d1f
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`(
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`Page 4 of 4
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