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` NDA 205029/S-008
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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 Mihir Taneja:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received
` December 22, 2020, and your amendment, pursuant to section 505(b)(2) of the Federal
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` Food, Drug, and Cosmetic Act (FDCA) for Epinephrine injection USP, 1 mg/mL.
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` This “Changes Being Effected in 30 days” supplemental new drug application provides
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` for labeling revisions dated for correcting the amount of inactive ingredients, sodium
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` chloride, hydrochloric acid and water for injection.
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is
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`approved, effective on the date of this letter, for use as recommended in the enclosed
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`agreed-upon 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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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Content of labeling must be identical to the enclosed labeling (text for the prescribing
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`information) with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the
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`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 titled SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
`nces/UCM072392.pdf.
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`Information on submitting SPL files using eLIST may be found in the guidance for
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`industry titled SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
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`U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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` NDA 205029/S-008
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` Page 2
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` The SPL will be accessible via publicly available labeling repositories.
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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 MS Word format,
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` that includes the changes approved in this supplemental application, as well as annual
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` reportable changes, and annotate each change. To facilitate review of your submission,
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` provide a highlighted or marked-up copy that shows all changes, as well as a clean
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` Microsoft Word version. The marked-up copy should provide appropriate annotations,
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` including supplement number(s) and annual report date(s).
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`CARTON AND CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to enclosed carton and
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`container labels, as soon as they are available, but no more than 30 days after they are
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`printed. Please submit these labels electronically according to the guidance for industry
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`Providing Regulatory Submissions in Electronic Format – Certain Human
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`Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications. For administrative purposes, designate this submission “Product
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`Correspondence – Final Printed Carton and Container Labels for approved NDA
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`205029/S-008.” Approval of this submission by FDA is not required before the labeling
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`is used.
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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 Elizabeth Eydelman, MPH, Regulatory Business Process
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`Manager, at (301) 796 - 5071.
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`Sincerely,
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`{See appended electronic signature page}
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`Gurpreet Gill-Sangha, PhD
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`Branch Chief, Branch 3
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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`Enclosures:
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`Content of Labeling
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`Carton and Container Labeling
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`U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Gurpreet
`Gill Sangha
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`Digitally signed by Gurpreet Gill Sangha
`Date: 6/23/2021 04:58:25PM
`GUID: 5135f2ad000117842392c50c36c7f28a
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