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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 205029/S-001
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` Food and Drug Administration
` Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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` Belcher Pharmaceuticals, LLC
` Attention: Mihir Taneja
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` Vice President
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` 6911 Bryan Dairy Road, Suite 210
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` Largo, FL 33777
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` Dear Mr. Taneja:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received
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` March 23, 2015, pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic
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` Act (FDCA) for Epinephrine Injection, USP.
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` We acknowledge receipt of your amendments dated June 18, July 2 and 22, and
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` October 14, 2015.
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` This “Prior Approval” supplemental new drug application provides for the use of Epinephrine
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` Injection, USP for induction and maintenance of mydriasis during intraocular surgery.
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text, which is identical to the labeling submitted on October 14, 2015.
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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 the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed package insert labeling, with the addition of any
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`labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible from publicly available labeling repositories.
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`Reference ID: 3837416
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`

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` NDA 205029/S-001
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` Page 2
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` Also within 14 days, amend all pending supplemental applications that includes labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes and
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` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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` should provide appropriate annotations, including supplement number(s) and annual report
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` date(s).
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` PROPRIETARY NAME
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`If you intend to have a proprietary name for this product, the name and its use in the labels must
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`conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit
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`a request for a proposed proprietary name review. (See the guidance for industry titled,
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`“Contents of a Complete Submission for the Evaluation of Proprietary Names”, at
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`cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
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`2008 through 2012”.)
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable. The requirement is inapplicable because the supplemental application
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`of epinephrine injection for the indication for induction and maintenance of mydriasis during
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`intraocular surgery is not a new active ingredient, new indication, new dosage form, new dosing
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`regimen or new route of administration of epinephrine injection.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
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`For more information about submitting promotional materials in eCTD format, see the draft
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`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
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`CM443702.pdf ).
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`Reference ID: 3837416
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`

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` NDA 205029/S-001
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` Page 3
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` You must submit final promotional materials and package insert(s), accompanied by a Form
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` FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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` FDA 2253 is available at
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` http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
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`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Michael Puglisi, Regulatory Project Manager, at (301) 796-0791.
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`Sincerely,
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`{See appended electronic signature page}
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`Wiley A. Chambers, M.D.
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`Deputy Director
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`Division of Transplant and Ophthalmology Products
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`Office of Antimicrobial Products
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`Office of New Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3837416
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`

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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`WILEY A CHAMBERS
`10/23/2015
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`Reference ID: 3837416
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