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204640Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204640Orig1s000 MEDICAL REVIEW(S) ADDENDUM TO MEDICAL OFFICER REVIEW Division of Pulmonary, Allergy, and Rheumatology Products (HFD-570) APPLICATION: NDA 204640 TRADE NAME: Adrenalin 30 mL vials APPLICANT/SPONSOR: JHP Pharmaceuticals, LLC USAN NAME: Epinephrine injection solution, USP, MEDICAL OFFICER: Peter Starke, MD 1 mg/mL (1:1000), 30 mL vials TEAM LEADER: Janet Maynard, MD CATEGORY: Non-selective alpha and beta adrenergic agonist (catecholamine) DATE: December 12, 2013 ROUTE: SC or IM SUBMISSIONS REVIEWED IN THIS DOCUMENT Document Date CDER Stamp Date Submission Comments Sept. 14, 2012 Sept. 14, 2012 N-000, SD-1 Original NDA submission for NDA 204-640, split from NDA 204-200 August 2, 2013 August 2, 2013 SD-2 PDUFA fee paid, NDA 204-640 reopened November 25, 2013 November 25, 2013 Medical Officer review of NDA 204640 REVIEW SUMMARY: This is an addendum to my clinical review dated November 25, 2013, for a 505(b)(2) application submitted by JHP Pharmaceuticals for the use of the currently marketed but unapproved 30 mL multiple- dose vial presentation of Adrenalin® (epinephrine injection, USP), 1mg/mL (1:1000), for the emergency treatment of allergic reactions (Type 1), including anaphylaxis [‘anaphylaxis’]. This application relies on the Agency’s previous findings of efficacy and safety for EpiPen for the treatment of anaphylaxis, and also cross-references to the approved 1 mL single-use vial Adrenalin product, which was approved on December 7, 2012. My original review noted the presence of chlorobutanol in the 30 mL vial presentation (which is not in the 1 mL vial presentation), stating that it does not affect the risk/benefit assessment for this presentation for indication of anaphylaxis, which remains favorable. It went on to note that chlorobutanol is also present in Twinject, an approved epinephrine auto-injector, thereby erroneously implying that this application relied in part on the Agency’s previous findings for the Twinject application. However, that is not the case. The review neglected to note that chlorobutanol is found in multiple other drug products, (b) and that the safety of chlorobutanol at (4) % in the proposed product is based on its listing on FDA’s inactive ingredient list: http://www.accessdata.fda.gov/scripts/cder/IIG/index.cfm. On this basis, the presence of chlorobutanol in this product is acceptable from a clinical perspective. OUTSTANDING ISSUES: None RECOMMENDED REGULATORY ACTION NDA: XAPPROVAL COMPLETE RESPONSE OTHER Reference ID: 3420753 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- PETER R STARKE 12/12/2013 Reference ID: 3420753 CLINICAL REVIEW Application Type NDA Application Number(s) 204-640 Priority or Standard Standard Submit Date(s) August 2, 2013 Received Date(s) August 2, 2013 PDUFA Goal Date June 2, 2014 Division / Office DPARP/OND Reviewer Name(s) Peter Starke, MD Review Completion Date November 25, 2013 Established Name Epinephrine injection, USP, 1mg/mL (Proposed) Trade Name Adrenalin® Therapeutic Class Non-selective alpha and beta adrenergic agonist (catecholamine) Applicant JHP Pharmaceuticals, LLC Formulation(s) Solution for injection, 30 mL multiple- dose vial Dosing Regimen IM or SC Injection Proposed Indication(s) Anaphylaxis (the indication of mydriasis during ophthalmologic surgery is not appropriate for this multiple-dose presentation) Intended Population(s) No age restrictions Reference ID: 3412361 Clinical Review ● Peter Starke, MD NDA 204-640 ● Adrenalin® (epinephrine) for injection, 1 mg/mL, 30 mL vial MEDICAL OFFICER REVIEW Division of Pulmonary, Allergy and Rheumatology Products (DPARP) SUBMISSIONS REVIEWED IN THIS DOCUMENT Document Date CDER Stamp Date Submission Comments Sept. 14, 2012 Sept. 14, 2012 N-000, SD-1 Original NDA submission for NDA 204-640, split from NDA 204-200 Sept. 20, 2012 Refuse to file letter August 2, 2013 August 2, 2013 SD-2 PDUFA fee paid, NDA 204-640 reopened August 14, 2013 August 14, 2013 SD-3 CMC data Sept. 16, 2013 Sept. 16, 2013 SD-4 Annotated labeling Sept. 17, 2013 Sept. 17, 2013 SD-5 Administrative information for Module 1, including requests for waivers of bioequivalence and pediatric studies Sept. 20, 2013 Sept. 20, 2013 SD-6 Administrative information for Module 1, including financial disclosure information, LOA, form 3674, etc. October 17, 2013 October 17, 2013 SD-9 Updated labeling (formatting issues addressed per filing letter request October 23, 2013 October 23, 2013 SD-10 Proprietary name review request (Adrenalin) November 1, 2013 November 1, 2013 SD-11 Support for request for biowaiver RECOMMENDED REGULATORY ACTION NDA/SUPPLEMENTS: X APPROVAL COMPLETE RESPONSE OTHER ACTION: 2 Reference ID: 3412361 Clinical Review ● Peter Starke, MD NDA 204-640 ● Adrenalin® (epinephrine) for injection, 1 mg/mL, 30 mL vial Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT......................................... 5 1.1 Recommendation on Regulatory Action ............................................................. 5 1.2 Risk Benefit Assessment.................................................................................... 5 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 6 1.4 Recommendations for Postmarket Requirements and Commitments ................ 6 1.5 Pediatric Issues .................................................................................................. 6 2 INTRODUCTION AND REGULATORY BACKGROUND ........................................ 6 2.1 Introduction......................................................................................................... 6 2.2 Regulatory Background...................................................................................... 8 2.3 Product Information ............................................................................................ 8 2.4 Tables of Currently Available Treatments for Proposed Indications ................... 8 2.5 Availability of Proposed Active Ingredient in the United States .......................... 9 2.5.1 Single-ingredient epinephrine products for injection .................................... 9 2.5.2 Other epinephrine-containing products ...................................................... 10 2.6 Important Safety Issues With Consideration to Related Drugs......................... 11 2.7 Summary of Presubmission Regulatory Activity Related to Submission .......... 11 2.8 Other Relevant Background Information .......................................................... 11 3 ETHICS AND GOOD CLINICAL PRACTICES....................................................... 11 3.1 Submission Quality and Integrity ...................................................................... 11 3.2 Compliance with Good Clinical Practices ......................................................... 11 3.3 Financial Disclosures........................................................................................ 11 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ......................................................................................................... 11 4.1 Chemistry Manufacturing and Controls ............................................................ 11 4.2 Clinical Microbiology......................................................................................... 13 4.3 Preclinical Pharmacology/Toxicology ............................................................... 13 4.4 Clinical Pharmacology...................................................................................... 14 4.4.1 Requirement for in vivo bioequivalence ..................................................... 14 4.4.2 Pharmacology of Epinephrine .................................................................... 14 3 Reference ID: 3412361 Clinical Review ● Peter Starke, MD NDA 204-640 ● Adrenalin® (epinephrine) for injection, 1 mg/mL, 30 mL vial 5 SOURCES OF CLINICAL DATA............................................................................ 15 5.1 Tables of Studies/Clinical Trials ....................................................................... 15 5.2 Review Strategy ............................................................................................... 15 5.3 Discussion of Individual Studies/Clinical Trials................................................. 15 6 REVIEW OF EFFICACY......................................................................................... 15 7 REVIEW OF SAFETY............................................................................................. 16 8 POSTMARKET EXPERIENCE............................................................................... 16 9 APPENDICES ........................................................................................................ 18 9.1 Literature Review/References .......................................................................... 18 9.2 Labeling Recommendations ............................................................................. 18 9.3 Advisory Committee Meeting............................................................................ 18 Table of Tables Table 1. Approved
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