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| Dockets Entered
On May 24, 2007
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| Docket #
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| Title
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| 2003E-0457
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| Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
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| 2005E-0245
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| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006N-0479
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| Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
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| 2006P-0398
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| Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)
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| 2007D-0021
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| Guidance for Industry; Advisory Committee Meetings: Preparation and Public Availability of Information Given to Advisory Committee Members
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| 2007M-0190
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| H060001 - Enterprise Vascular Reconstruction Device and Delivery System
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| 2007N-0069
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| Animal Drug User Fee Act; Public Meeting
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| 2007P-0116
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| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
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| 2007P-0214
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| ANDA Suitability for Cefazolin Injection, USP 2 g Vials
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| 2003E-0457
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| Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2005E-0245
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| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| C 1
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| Novartis Vaccines and Diagnostics, Inc.
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| Vol #:
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| 1
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| LET 5
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| Novartis Vaccines and Diagnostics, Inc.
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| Vol #:
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| 1
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| C 31
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| E. Fuller
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| Vol #:
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| 1
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| C 32
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| Jonathan Sprouts, Inc.
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| Vol #:
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| 1
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| C 33
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| R. Duggan
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| Vol #:
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| 1
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| C 34
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| S. Michaels
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| Vol #:
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| 1
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| C 35
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| R.H. Miller, Jr.
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| Vol #:
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| 1
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| C 36
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| C. Jurovic
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| Vol #:
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| 1
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| C 37
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| L. Schuitz
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| Vol #:
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| 1
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| C 38
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| M. Luketich
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| Vol #:
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| 1
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| C 39
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| No signature
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| 1
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| C 40
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| S. Mentley
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| Vol #:
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| 1
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| C 41
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| D. Daugherty
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| Vol #:
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| 1
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| C 42
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| T. Garvin
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| Vol #:
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| 1
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| C 43
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| K. Oyer
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| Vol #:
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| 1
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| C 6
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| North Shore Long Island Jewish Health System
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| Vol #:
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| 1
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| 2006N-0479
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| Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
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| C 1
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| Cosmetic, Toiletry, and Fragrance Association CTFA
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| Vol #:
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| 1
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| C 2
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| Avon Products, Inc.
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| Vol #:
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| 1
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| 2006P-0398
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| Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)
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| SUP 1
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| Frommer Lawrence & Haugh LLP
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| Vol #:
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| 1
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| 2007D-0021
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| Guidance for Industry; Advisory Committee Meetings: Preparation and Public Availability of Information Given to Advisory Committee Members
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| C 2
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| National Health Council
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| Vol #:
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| 1
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| C 3
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| C 3
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| University of Florida
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| Vol #:
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| 1
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| EC 34
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 1
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| EC 35
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| University of Virginia
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| Vol #:
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| 1
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| EC 36
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| American Association for Justice
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| Vol #:
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| 1
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| EC 37
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| Union of Concerned Scientists
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| Vol #:
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| 1
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| EC 38
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| Advanced Medcial Technology Association
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| Vol #:
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| 1
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| EC 39
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| GMA/FPA
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| Vol #:
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| 1
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| EC 40
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EC 41
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| OMB Watch
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| Vol #:
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| 1
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| EC 42
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| PhRMA
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| Vol #:
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| 1
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| EC 43
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| AANS/CNS Washington Office
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| Vol #:
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| 1
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| EC 44
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| Committee of Ten Thousand
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| Vol #:
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| 1
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| EC 45
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| The Center for Regulatory Effectiveness
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| Vol #:
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| 1
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| EC 46
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| American Society of Clinical Oncology
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| Vol #:
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| 1
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| 2007M-0190
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| H060001 - Enterprise Vascular Reconstruction Device and Delivery System
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| AAV 1
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| Cordis Neurovascular, Inc.
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| Vol #:
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| 1
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| 2007N-0069
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| Animal Drug User Fee Act; Public Meeting
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| C 1
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| Putney
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 221
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| Ebel, Amy
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| Vol #:
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| 7
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| EAPE 222
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| jkjkl, sdkjfl
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| Vol #:
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| 7
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| EAPE 223
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| Hill, Edward
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| Vol #:
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| 7
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| EAPE 224
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| Farber, Timothy
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| Vol #:
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| 7
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| EAPE 225
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| Flottman, Thomas
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| Vol #:
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| 7
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| LET 3
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| Mylan Laboratories Inc. and Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| LET 4
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| Heller Ehrman LLP
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| Vol #:
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| 2
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| 2007P-0116
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| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
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| | |
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| LET 1
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| Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| LET 2
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| Heller Ehrman LLP
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| Vol #:
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| 1
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| 2007P-0214
|
| ANDA Suitability for Cefazolin Injection, USP 2 g Vials
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| CP 1
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| Sandoz, Inc.
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| Vol #:
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| 1
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