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| Dockets Entered
On September 14, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1999V-2629
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| Laser Light Show (Gemini Laser Corporation)
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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| 2006O-0232
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| 2006P-0114
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| Refrain from taking administrative action regarding approval and/or effective date of final approval of any and all ANDAs for a generic version of Metrogel-Vaginal 0.75%
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0242
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| Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules
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| 2006P-0263
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| ANADA suitability for Neomycin
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| 2006P-0265
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| to permit an ANDA Suitability for Cefdinir
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| 2006P-0281
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| Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet
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| 2006P-0285
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| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
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| 2006P-0286
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| Determine Whether Phoslo (calcium acetate) Capsules eq169 mg calcium have been voluntarily withdrawn from sale for safety or effcacy reasons.
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| 2006P-0291
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| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| 2006P-0305
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| Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| 2006P-0313
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| Removal of labeling for MediSense Precision Advanced Diabetes Management System
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| 1976N-0052N
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| OTC Nasal Decongestants
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| SUP 9
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| Arnold & Porter, LLP
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| Vol #:
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| 104
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| C 140
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| Pharma Corp., Inc.
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| C 133
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| Pharma Corp., Inc.
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| Vol #:
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| 10
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| EC 7
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| New Zealand Embassy
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| Vol #:
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| 9
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET 895
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| FDA/CFSAN to TJ Panorama Inc
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| Vol #:
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| 27
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| LET 896
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| FDA/CFSAN to BrandStorm Inc
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| Vol #:
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| 27
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| LET 897
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| FDA/CFSAN to Blaine Pharmaceuticals
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| Vol #:
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| 27
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| LET 898
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| FDA/CFSAN to Beulah Land Corporation
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| Vol #:
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| 27
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| LET 899
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| FDA/CFSAN to Nutrition212, Inc
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| Vol #:
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| 27
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| 1999V-2629
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| Laser Light Show (Gemini Laser Corporation)
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| VRA 3
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| FDA/DDMB to Gemini Laser Corporation
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| Vol #:
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| 1
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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| WDL 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 23
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| Mr. Martin Linskey
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| Vol #:
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| 8
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| SUP 4
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| sanofi-aventis US LLC
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| Vol #:
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| 7
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 64
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| A. Brewer
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| Vol #:
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| 5
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| C 6
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| Scarab Genomics, LLC
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| Vol #:
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| 1
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| SUP 1
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| Medi-Flex, Inc.
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| Vol #:
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| 1
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| C 10
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| Pactiv Corporation
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| Vol #:
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| 7
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| C 11
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| Matforsk AS
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| Vol #:
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| 7
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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| C 1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| C 7
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| Pharma Corp.
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| Vol #:
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| 1
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| EXT 3
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| American Pet Products Manufacturers Association (APPMA)
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| Vol #:
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| 1
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| 2006O-0232
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0114
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| Refrain from taking administrative action regarding approval and/or effective date of final approval of any and all ANDAs for a generic version of Metrogel-Vaginal 0.75%
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| LET 1
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| FDA/DDMB to Foley & Lardner LLP
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| Vol #:
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| 1
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| LET 1
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| FDA/DDMB to Mylan Laboratories Inc.
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| Vol #:
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| 1
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| C 1
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| S. Ebert, PharmD., FCCP
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| Vol #:
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| 1
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 695
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| Mr. John McAdams
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| Vol #:
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| 5
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| EC 696
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| Ms. Brenda Willoughby
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| Vol #:
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| 5
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| 2006P-0242
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| Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules
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| C 1
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| D. Lowe
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| Vol #:
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| 2
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| 2006P-0263
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| ANADA suitability for Neomycin
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0265
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| to permit an ANDA Suitability for Cefdinir
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0281
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| Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| | | | | | | | |
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| 2006P-0285
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| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0286
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| Determine Whether Phoslo (calcium acetate) Capsules eq169 mg calcium have been voluntarily withdrawn from sale for safety or effcacy reasons.
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|
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0291
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| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0305
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| Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0313
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| Removal of labeling for MediSense Precision Advanced Diabetes Management System
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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|
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| C 1
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| Society of Infectious Diseases Pharmacists (SIDP)
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| Vol #:
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| 2
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