DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring, MD 20993
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`ANDA 090218
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`Sandoz, Inc.
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` 2555 West Midway Blvd.
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`Broomfield, CO 80038
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`Jean Domenico
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`Attention:
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`Associate Director, Regulatory Affairs
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`Dear Madam:
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`This is in reference to your abbreviated new drug application (ANDA) dated December 27, 2007,
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`submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (the Act), for
`Glatopa (Glatiramer Acetate) Injection, 20 mg/mL, 1 mL prefilled syringe.
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`Reference is also made to the Complete Response letter issued by this office on August 19, 2014,
`and to your amendments dated October 1 and November 17, 2014.
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`We have completed the review of this ANDA and have concluded that adequate information has
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`been presented to demonstrate that the drug is safe and effective for use as recommended in the
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`submitted labeling. Accordingly the ANDA is approved, effective on the date of this letter.
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`The Office of Generic Drugs has determined your Glatopa (Glatiramer Acetate) Injection,
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`20 mg/mL, 1 mL prefilled syringe meets the standards for approval (including those for active
`ingredient sameness and bioequivalence) and, therefore, is therapeutically equivalent to the
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`reference listed drug product (RLD), Copaxone® (Glatiramer Acetate) Injection, 20 mg/mL,
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`1 mL prefilled syringe, of Teva Pharmaceuticals USA.
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`Under section 506A of the Act, certain changes in the conditions described in this ANDA require
`an approved supplemental application before the change may be made.
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`Please note that if FDA requires a Risk Evaluation & 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 Act.
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`Postmarketing reporting requirements for this ANDA are set forth in 21 CFR 314.80-81 and
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`314.98. The Office of Generic Drugs should be advised of any change in the marketing status of
`this drug.
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`Promotional materials may be submitted to FDA for comment prior to publication or
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`dissemination. Please note that these submissions are voluntary. If you desire comments on
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`proposed launch promotional materials with respect to compliance with applicable regulatory
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`Biogen Exhibit 2161
`Mylan v. Biogen
`IPR 2018-01403
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`Page 1 of 3
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`requirements, we recommend you submit, in draft or mock-up form, two copies of both the
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` promotional materials and package insert(s) directly to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
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`Beltsville, MD 20705
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`We call your attention to 21 CFR 314.81(b)(3) which requires that all promotional materials be
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`submitted to the Office of Prescription Drug Promotion with a completed Form FDA 2253 at the
`time of their initial use.
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`You have been requested to provide information after the drug application has been approved.
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`Any information submitted to meet the conditions requested in this letter is considered a “Post
`Approval Commitment Response”. To alert the Office of Generic Drug staff to the fact that you
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`are providing post approval commitment information, please designate your submission in your
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`cover letter as “POST APPROVAL COMMITMENT RESPONSE”.
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`The Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III)
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`established certain provisions 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-
`identification requirement and payment of an annual facility fee. Self-identification must occur
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`by June 1 of each year for the next fiscal year. Facility fees must be paid each year by the date
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`specified in the Federal Register notice announcing facility fee amounts. All finished dosage
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`forms (FDFs) or active pharmaceutical ingredients (APIs) manufactured in a facility that has not
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`met its obligations to self-identify or to pay fees when they are due will be deemed misbranded.
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`This means that it will be a violation of federal law to ship these products in interstate commerce
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`or to import them into the United States. Such violations can result in prosecution of those
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`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
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`States.
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
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`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
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm,
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`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
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`files using eLIST may be found in the guidance for industry titled “SPL Standard for Content of
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`Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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`Digitally signed by William P. Rickman -S
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`DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People,
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`0.9.2342.19200300.100.1.1=1300043242, cn=William P. Rickman -S
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`Date: 2015.04.16 11:11:36 -04'00'
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`Sincerely yours,
`William P.
`Rickman -S
`Carol A. Holquist, RPh
`Acting Deputy Director
`Office of Regulatory Operations
`Office of Generic Drugs
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`Center for Drug Evaluation and Research
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