`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`
`APPLICATION NUMBER:
`
`205029Orig1s000
`
`Epinephrine Injection
`
`Trade Name:
`
`Generic Name:
`
`Sponsor:
`
`Approval Date:
`
`Indications:
`
`Epinephrine Injection
`
`Belcher Pharmaceuticals, LLC
`
`July 29, 2014
`
` To Increase Mean Arterial Blood Pressure in
`Hypotension Associated with Septic Shock.
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`205029Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`X
`X
`X
`
`X
`X
`
`
`X
`X
`
`X
`X
`X
`X
`X
`
`X
`X
`
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology / Virology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`205029Orig1s000
`APPROVAL LETTER
`
`
`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`NDA 205029
`
`Belcher Pharmaceuticals, LLC
`Attention: Mihir Taneja
`Vice President
`6911 Bryan Dairy Road
`Suite 210
`Largo, FL 33777
`
`Dear Mr. Taneja:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`Please refer to your New Drug Application (NDA) dated November 30, 2012, received December 4,
`2012, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for
`epinephrine injection 1 mg/mL.
`
`We acknowledge receipt of your amendments dated January 29, June 13, and July 1, 9 and 25, 2014.
`
`The January 29, 2014, submission constituted a complete response to our October 4, 2013, action letter.
`
`This new drug application provides for the use of epinephrine injection to increase mean arterial blood
`pressure in hypotension associated with septic shock.
`
`We have completed our review of this application, as amended. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`CONTENT OF LABELING
`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. 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,
`available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM0723
`92.pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`Submit final printed carton and immediate container labels that are identical to the carton and immediate
`container labels submitted on July 1, 2014, 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
`
`Reference ID: 3600866
`
`
`
`NDA 205029
`
`Page 2
`
`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.” Approval of this submission by FDA is not required before the labeling is used.
`
`Marketing the product with FPL that is not identical to the approved labeling text may render the product
`misbranded and an unapproved new drug.
`
`ADVISORY COMMITTEE
`Your application for epinephrine injection was not referred to an FDA advisory committee because
`outside expertise was not necessary; there were no controversial issues that would benefit from advisory
`committee discussion.
`
`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 Contents of a Complete Submission for
`the Evaluation of Proprietary Names, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm07506
`8.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through
`2012”.)
`
`REQUIRED PEDIATRIC ASSESSMENTS
`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, deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable.
`
`PROMOTIONAL MATERIALS
`You may request advisory comments on proposed introductory advertising and promotional labeling. To
`do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed materials in draft or
`mock-up form with annotated references, and the package insert to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the package
`insert, at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Form 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
`
`Reference ID: 3600866
`
`
`
`NDA 205029
`
`Page 3
`
`information about submission of promotional materials to the Office of Prescription Drug Promotion
`(OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80
`and 314.81).
`
`If you have any questions, please call Russell Fortney, Regulatory Project Manager at (301) 796-1068.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Norman Stockbridge, M.D., Ph.D.
`Director
`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`ENCLOSURE: Draft Labeling
`
`Reference ID: 3600866
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`NORMAN L STOCKBRIDGE
`07/29/2014
`
`Reference ID: 3600866
`
`