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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 205029/S-004
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` Belcher Pharmaceuticals, LLC
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` 6911 Bryan Dairy Road
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` Suite 210
` Largo, FL 33777
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`Attention:
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`Mihir Taneja
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`Vice President
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Dear Mr. Taneja:
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`Please refer to your Supplemental New Drug Application (sNDA) dated March 10, 2016,
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`received March 10, 2016, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Epinephrine Injection, USP (epinephrine, 1:1000), 1
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`mg/mL.
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`We also refer to our letter dated February 9, 2016, notifying you, under Section 505(o)(4) of the
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`FDCA, of new safety information that we believe should be included in the labeling for
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`Epinephrine Injection, USP (epinephrine, 1:1000). This information pertains to reports of
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`lacerations and embedded needles after epinephrine injection and post-marketing adverse event
`reports of serious infection (e.g. Clostridium perfringens) at the injection site following
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`epinephrine injection for anaphylaxis.
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`This supplemental new drug application provides for revisions to the labeling for Epinephrine
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`Injection consistent with our February 9, 2016, letter and the changes agreed upon in our March
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`24, and 31, and April 15, 2016, correspondences.
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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.
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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
` 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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`Reference ID: 3932746
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` NDA 205029/S-004
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` Page 2
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`of labeling must be identical to the enclosed labeling text for the package insert, with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`well as annual 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
` “SPL Standard for Content of 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 from publicly available labeling repositories.
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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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`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.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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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 Carol F. Hill, Senior Regulatory Health Project Manager for
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`Safety, at (301) 796-1226.
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`Sincerely,
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`{See appended electronic signature page}
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`Sally Seymour, MD
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`Deputy Director for Safety
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`Reference ID: 3932746
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`NDA 205029/S-004
`Page 3
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`ENCLOSURE(S):
`Content of Labeling
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`Division of Pulmonary, Allergy, and Rheumatology
`Products
`Office of Drug Evaluation II
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`Reference ID: 3932746
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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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`SALLY M SEYMOUR
`05/18/2016
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`Reference ID: 3932746
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`(
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