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Dockets Management

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

Page created on June 19, 2007 ue

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