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| Dockets Entered
On September 29, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1999D-0054
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| Electronic Format---NDA's
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| 2004E-0425
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| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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| 2004N-0234
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| Annual Guidance Agenda
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0397
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| Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension
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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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| 2006P-0399
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| To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET 900
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| FDA/CFSAN to Botanical Laboratories Inc
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| Vol #:
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| 27
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| LET 901
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| FDA/CFSAN to New Chapter Inc
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| Vol #:
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| 27
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| LET 902
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| FDA/CFSAN to PuraPham International (HK) Ltd c/o Amerisearch Inc
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| Vol #:
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| 27
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| LET 903
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| FDA/CFSAN to GUNA Inc
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| Vol #:
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| 27
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| LET 904
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| FDA/CFSAN to Medicine Chest Inc
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| Vol #:
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| 27
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| 1999D-0054
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| Electronic Format---NDA's
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2004E-0425
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| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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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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| 2004N-0234
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| Annual Guidance Agenda
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| C 2
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| Amegen, Inc.
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| Vol #:
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| 1
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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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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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18141
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| B. Nelson
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| Vol #:
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| 196
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| C 18142
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| T. Nelson
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| Vol #:
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| 196
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| C 18143
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| K. Carnley
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| Vol #:
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| 196
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| C 18144
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| H. Odom
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| Vol #:
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| 196
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| C 18145
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| B. Tinsley
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| Vol #:
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| 196
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| C 18146
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| B. Tinsley
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| Vol #:
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| 196
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| C 18147
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| J. Bonilla
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| Vol #:
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| 196
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| C 18148
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| L. Palmer
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| Vol #:
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| 196
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| C 18149
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| S. Guice
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| Vol #:
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| 196
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| C 18150
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| L. Parker
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| Vol #:
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| 196
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| C 18151
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| C. Rocha
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| Vol #:
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| 196
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| C 18152
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| N. Horner
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| Vol #:
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| 196
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| C 18153
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| R. Hafner
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| Vol #:
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| 196
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| C 18154
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| R. Bernhoft
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| Vol #:
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| 196
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| C 18155
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| C. Lyon
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| Vol #:
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| 196
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| C 18156
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| L. Cox
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| Vol #:
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| 196
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| C 18157
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| M. Stieber
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| Vol #:
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| 196
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 34
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| Mrs. Bonnie Klein
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| Vol #:
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| 2
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| EC 35
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| Mrs. Malinda Rauschert
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| Vol #:
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| 2
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| GDL 1
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| Background Material
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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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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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| C 7
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| M. Hanson
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| Vol #:
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| 1
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| C 8
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| J. Ferreira
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| Vol #:
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| 1
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| EC 10
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| Insitute for Agriculture and Trade Policy
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| Vol #:
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| 1
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| EC 2
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| Pfizer Inc.
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 726
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| Dr. Mona Mehdy
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| Vol #:
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| 3
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| 2006P-0397
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| Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension
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| ACK 1
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| FDA/ DDM to Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| |
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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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| ACK 1
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| FDA/DDM to Frommer Lawrence & Haug, LLP
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| Vol #:
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| 1
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| CP 1
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| Frommer Lawrence & Haug, LLP
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| Vol #:
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| 1
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| 2006P-0399
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| To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons
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| ACK 1
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| FDA/DDM to Beckloff Associates
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| Vol #:
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| 1
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| CP 1
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| Beckloff Associates
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| Vol #:
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| 1
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