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`,.,. .........
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`ADMINISTRATION
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`NDA 205029/S-006
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`SUPPLEMENT APPROVAL
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` Belcher Pharmaceuticals, LLC
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` Attention: Mihir Taneja
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` Vice President
` 6911 Bryan Dairy Road
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` Suite 210
` Largo, FL, 33777
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`Dear Mr. Taneja:
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`Please refer to your supplemental new drug application (sNDA) dated June 28, 2019,
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`received June 28, 2019, submitted pursuant to section 505(b)(2) of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for Epinephrine Injection USP, injection.
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`This Prior Approval supplemental new drug application provides for revisions to labeling
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`pursuant to the Pregnancy Lactation and Labeling Rule, (PLLR).
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information), with the addition of any labeling changes in pending “Changes
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`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4855241
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` NDA 205029/S-006
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` Page 2
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` Also within 14 days, amend all pending supplemental applications that include labeling
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` changes for this NDA, including CBE supplements for which FDA has not yet issued an
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` action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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` format, that includes the changes approved in this supplemental application, as well as
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` annual reportable changes. To facilitate review of your submission(s), provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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` Word version. The marked-up copy should provide appropriate annotations, including
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` supplement number(s) and annual report date(s).
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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, please call Michael Monteleone, Associate Director for
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`Labeling, at (301) 796-1952.
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`Sincerely,
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`{See appended electronic signature page}
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`Mary Ross Southworth, PharmD
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`Deputy Director for Safety
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`Division of Cardiology and Nephrology
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`Office of Cardiology, Hematology, Endocrinology,
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`and Nephrology
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4855241
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`Signature Page 1 of 1
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`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/
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`MARY R SOUTHWORTH
`09/10/2021 02:49:27 PM
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`Reference ID: 4855241
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