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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 205029/S-002
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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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`Belcher Pharmaceuticals, LLC
`6911 Bryan Dairy Road, Suite 210
`Largo, FL 33777
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`Attention: Mihir Taneja
`Vice President
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`Dear Mr. Taneja :
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`Please refer to your supplemental New Drug Application (sNDA) dated April 14, 2015, received
`April 15, 2015, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic
`Act (FDCA), for Epinephrine Injection.
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`This “Prior Approval” supplemental new drug application provides for the use of Epinephrine
`Injection, USP for emergency treatment of allergic reactions (Type I) including anaphylaxis.
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`APPROVAL & LABELING
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`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
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
`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
`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
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`Reference ID: 3886429
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`NDA 205029/S-002
`Page 2
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels and carton and immediate-container labels submitted on
`February 9, 2016, as soon as they are available, but no more than 30 days after they are printed.
`Please submit these labels electronically according to the guidance for industry Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008). Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Final Printed Carton
`and Container Labels for approved NDA 205029/S-002.” Approval of this submission by
`FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
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`PROPRIETARY NAME
`If you intend to have a proprietary name for this product, the name and its use in the labels must
`conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit
`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
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/u
`cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
`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
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`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
`of epinephrine injection for the indication for emergency treatment of allergic reactions (Type I)
`including anaphylaxis is not a new active ingredient, new indication, new dosage form, new
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`dosing regimen or new route of administration of epinephrine injection.
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`PROMOTIONAL MATERIALS
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Reference ID: 3886429
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`NDA 205029/S-002
`Page 3
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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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
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`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
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Colette Jackson, Senior Regulatory Health Project Manager, at
`(301) 796-1230.
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`Sincerely,
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`{See appended electronic signature page}
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`Lydia Gilbert-McClain, M.D.
`Deputy Director
`Division of Pulmonary, Allergy, and Rheumatology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURES: Package Insert and Carton and Container Labeling
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`Reference ID: 3886429
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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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`LYDIA I GILBERT MCCLAIN
`02/11/2016
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`Reference ID: 3886429
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