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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 205029
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`Food and Drug Administration
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` Silver Spring MD 20993
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` NDA 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 New Drug Application (NDA) dated November 30, 2012, received December 4,
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`2012, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for
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`epinephrine injection 1 mg/mL.
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`We acknowledge receipt of your amendments dated January 29, June 13, and July 1, 9 and 25, 2014.
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`The January 29, 2014, submission constituted a complete response to our October 4, 2013, action letter.
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`This new drug application provides for the use of epinephrine injection to increase mean arterial blood
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`pressure in hypotension associated with septic shock.
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`We have completed our review of this application, as amended. It is approved, effective on the date of
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`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
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`[21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug
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`registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of
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`labeling must be identical to the enclosed labeling. Information on submitting SPL files using eLIST may
`be found in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As,
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`available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM0723
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`92.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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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 carton and immediate
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`container labels submitted on July 1, 2014, as soon as they are available, but no more than 30 days after
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`they are printed. Please submit these labels electronically according to the guidance for industry
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`Reference ID: 3600866
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` Page 2
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` NDA 205029
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` Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
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` and Related Submissions Using the eCTD Specifications (June 2008). Alternatively, you may submit 12
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` paper copies, with 6 of the copies individually mounted on heavy-weight paper or similar material. For
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` administrative purposes, designate this submission “Final Printed Carton and Container Labels for
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` approved NDA 205029.” Approval of this submission by FDA is not required before the labeling is used.
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` Marketing the product with FPL that is not identical to the approved labeling text may render the product
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` misbranded and an unapproved new drug.
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`ADVISORY COMMITTEE
`Your application for epinephrine injection was not referred to an FDA advisory committee because
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`outside expertise was not necessary; there were no controversial issues that would benefit from advisory
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`committee discussion.
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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 conform
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`to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit a request for a
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`proposed proprietary name review. (See the guidance for industry Contents of a Complete Submission for
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`the Evaluation of Proprietary Names, available at
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm07506
`8.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through
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`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
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`ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are
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`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, deferred, or inapplicable.
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`We are waiving the pediatric study requirement for this application because necessary studies are
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`impossible or highly impracticable.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional labeling. To
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`do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed materials in draft or
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`mock-up form with annotated references, and the package insert to:
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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
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the package
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`insert, at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Form FDA
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`2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf. 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 more
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`Reference ID: 3600866
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` NDA 205029
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`information about submission of promotional materials to the Office of Prescription Drug Promotion
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`(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
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`and 314.81).
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`If you have any questions, please call Russell Fortney, Regulatory Project Manager at (301) 796-1068.
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` Page 3
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`Sincerely,
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`{See appended electronic signature page}
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`Norman Stockbridge, M.D., Ph.D.
`Director
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`Division of Cardiovascular and Renal Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`ENCLOSURE: Draft Labeling
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`Reference ID: 3600866
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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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`NORMAN L STOCKBRIDGE
`07/29/2014
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`Reference ID: 3600866
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