• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Regulatory Information

  • Print
  • Share
  • E-mail

2006 Chronological List of Petitions and Advisory Opinions

 To view actual documents, make a note of the docket number, go to regulations.gov and enter the docket number in the search box. You will then get everything associated with that docket number.

Interim Response is not a final decision on the petition.

January | February | March | April | May | June | July | August | September | October | November | December

Date Filed Docket # Name of Petitioner/Subject Matter Disposition
January      
01/04/2006 2006P-0001 Sepracor Inc./Date of Approval for Lunesta (Eszopiclone) Tablets Interim Response 06/29/2006
01/06/2006 2006P-0002 Lachman Consultant Services, Inc./Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA) Pending
01/06/2006 2006P-0007 Lachman Consultant Services, Inc./Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
Approved 01/16/2007
01/06/2006 2006V-0013 Stace Smith Pro Rodeos/Projector for a Laser Light Show Pending
01/12/2006 2006P-0030 Number not used Pending
01/13/2006 2006V-0027 NVEC (Night Vision Equipment Company)/Laser Light Show regarding GCO-1A and GCP-2 Pending
01/19/2006 2006P-0039 Food and Drug Law Class/FDA issue new labeling requirements for caffeinated food products Pending
01/20/2006 2006A-0041 Litron Laboratories/genetic toxicology testing: the Ames Assay, Mouse Lymphoma Assay and the Micronucleus Assay
Pending
01/23/2006 2006P-0047 SPEC Pharma/Refrain from Approval any ANDA for Celestone Soluspan Approved 06/22/2006
01/23/2006 2006V-0048 TIA Products/Laser Light Show Pending
01/24/2006 2006P-0049 Synthetic Organic Chemical Manufacturers Association's/reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities
Interim Response 07/17/2006
01/25/2006 2006P-0052 Lachman Consultant Services, Inc./Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21- 360), has been voluntarily withdrawn for safety or effectiveness reasons
Interim Response 07/27/2006; Answer 02/02/2007 N1 72FR5061 2/2/07
01/25/2006 2006P-0054 Alcohol Monitoring Systems/513(f) Petition for the SCRAM Bracelet (and Collectively, the SCRAM System) as a Class I Medical Device
Pending
01/26/2006 2006V-0053 Fascanition Laser Systems/Laser Light Show Pending
01/27/2006 1988N-0258 Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987; Guideline Denied 08/08/2006
01/27/2006 1992N-0297 Pharmaceutical Distributors Assciation/Prescription Drug Marketing Act of 1987, Drug Amds of 1992 Denied 08/08/2006
01/27/2006 2006V-0055 William E. Komassa/Variance for a laser Light Show Pending
Top      
February      
02/01/2006 2006P-0060 MacLeon Pharmaceuticals Inc./ANADA for Unibute Granules 200 mg phenylbutazone per g of of granules instant of paste
Approved 04/04/2006
02/08/2006 2006P-0068 Covington & Burling/Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety or effectiveness reasons
Withdrawn 06/28/2006
02/09/2006 2006P-0070 Pfizer Inc./Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
Pending
02/10/2006 2006P-0071 Regulatory & Clinical Research Institute, Inc (RCRI)/513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
Interim Response 08/23/2006
02/10/2006 2006P-0072 Olsson,Frank and Weeda, P.C./ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL Withdrawn 03/30/2006
02/13/2006 2006V-0073 Adventure Zone/Projector for a Laser Light Show Approved 05/24/2006
02/13/2006 2006P-0074 Lachman Consultant Services, Inc./Determine whether Doxycycline Tablets, 75 mg (ANDA 65-070), held by Par Pharmaceuticals has been voluntarily withdrawn from sale for safety or efficacy reasons
Withdrawn 04/19/2006
02/15/2006 2006P-0069 The Quaker Oats Company/Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
Pending
02/15/2006 2006V-0076 Renishaw/Laser Light Show Pending
02/16/2006 2006P-0077 Pfizer Inc./Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007 Interim Response 08/14/2006
02/22/2006 2006P-0084 King & Spalding/ANDA Suitability for 1.25 mg, 2.50 mg, 5 mg, and 10 mg Ramipril Tablets Pending
02/22/2006 2006P-0085 American Association of Neurological Surgeons/To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements Pending
02/23/2006 2006P-0086 Lachman Consultant Services, Inc. /To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA) Approved 08/18/2006
02/24/2006 2006P-0087 Lachman Consultant Services, Inc./To declare that the drug product, Propoxyphene Napsylate, 50 mg and Acetaminophen, 300 mg tablets are suitable for consideration in an abbreviated new drug application (ANDA) Pending
02/27/2006 2006P-0089 Korein Tillery LLC/Stay approval of all supplements to biologics licenses issued to Genentech (BLA# 103705) and Biogen (BLA# 103737) for Rituxan (Rituximab) Interim Response 08/28/2006
02/28/2006 2006P-0090 Public Citizen's Health Research Group/Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products. Interim Response 08/22/2006
02/28/2006 2004P-0513 Beth Rosenshein/to amend regulation update 'Estrogens Increase The Risk of Endometrial Cancer prescribing info of all strengths of Premarin tablets Pending
02/28/2006 2006P-0094 The Sugar Association/To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA Interim Response 09/11/2006
Top      
March      
03/01/2006 2006P-0092 Amphastar Pharmaceuticals, Inc./Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
Interim Response 08/22/2006
03/01/2006 2006P-0093 ECO Animal Health/ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128- 409, Merial LTD., Denied 05/05/2006
03/02/2006 2006P-0095 Sandoz, Inc./ANDA suitability for a Piperacillin and Tazobactam for Injection, 13.5 g pharmacy bulk vial Pending
03/02/2006 2006P-0098 Monosol Rx, LLC/Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo
Withdrawn 05/01/2006
03/03/2006 2006P-0096 Monterey Mushrooms Inc./Regarding the following non-binding package requirement for a minimum of - 1/8 inch holes in each package of mushrooms Interim Response 11/03/2006
03/03/2006 2006V-0097 Night Vision Equipment Co./Laser Light Show Pending
03/07/2006 2006P-0101 American Beekeeping Federation, Inc. et al/Petition for Review of Codex Standard for Honey Under 21 CFR 130.6 Interim Response 08/31/2006
03/08/2006 2006P-0102 Lord Bissell Brook/Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER Interim Response 09/05/2006
03/09/2006 2006P-0103 Lachman Consultant Services, Inc./Declare that Temazepam Orally Disintegrating Tablets, 7.5 mg, 15 mg, 22,5 mg, and 30 mg is suitable for submission as an ANDA. Withdrawn 03/29/2007
03/14/2006 2006V-0110 Granger Community Church/ Laser Display Device Pending
03/15/2006 2006V-0111 Aurora Projections/Projector for a Laser Light Show Approved 06/28/2006
03/15/2006 2006P-0114 Foley & Lardner LLP/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% Interim Response 09/11/2006
03/15/2006 2006P-0117 QPharma, LLC/Declare that Omeprazole Tablets, 20 mg (proposed formulation), is suitable for submission as an ANDA Pending
03/15/2006 2006V-0119 Mero Productions/Laser Light Show Pending
03/16/2006 2006P-0120 EnviroWatch, Inc./Enforce ban on carbon monoxide in the packaging of fresh tuna and fresh tuna that is subsequently frozen Pending
03/17/2006 2006P-0122 Lachman Consulant Services, Inc./ANDA Suitability for Cetirizine Hydrochloride Orally Disintegrating Tablets, 5 mg and 10 mg Pending
03/17/2006 2006P-0123 Mylan Laboratories Inc./Request that all applicants for fentanyl transdermal systems conduct a study to support the safe of an overly with their repective fentanyl transdermal products Interim Response 09/11/2006
03/17/2006 2006P-0124 ViroPharma/Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules Pending
03/20/2006 2006P-0125 Lachman Consultant Services, Inc./Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons Interim Response 09/13/2006
03/20/2006 2006P-0126 Richard S. Wyde, Esq. & Roberta Kraus Wyde, MPH, PhD/Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie" Interim Response 08/25/2006
03/21/2006 2006N-0100 Center for Desease Control and Prevention/Medical Devices; Immunology and Microbiology Devices; Classification of Reagents for Detection of Specific Novel Influenza A Viruses Pending
03/22/2006 1976N-0052N Number not used/OTC Nasal Decongestants Pending
03/24/2006 2006P-0131 AAC Consulting Group/ANDA Suitability for Epirubicin Hydrochloride Injection, 2mg/ mL vial sizes of 10 mg/ 5 mL, 20 mg/ 10 mL and 200 mg/ 100 mL Pending
03/24/2006 2004P-0457 Endotec, Inc./Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis Interim Response 04/11/2006; Answer 08/23/2007
03/27/2006 2006V-0134 Fun City LLC/Laser Light Show Pending
03/27/2006 1981N-0022 Wyeth/OTC Weight Control Drug Products for Human Use Interim Response 09/25/2006
03/27/2006 1976N-0052N Wyeth/OTC Nasal Decongestants Interim Response 09/25/2006
03/27/2006 2006P-0135 National Coalition for Cancer Survivorship and American Society of Clinical Oncology/Issue Guidance to Industry outlining procedures and standards for initiating an "expanded access program" for unapproved drugs Pending
03/27/2006 2006P-0140 Connetics Corporation/To withhold approval of any ANDA for a generic version of acitretin capsules Interim Response 09/15/2006
03/27/2006 2006V-0141 Mathew Raftery/Laser Light Show Pending
03/27/2006 2006V-0142 XENO13 - Phantom Dynamics/Laser Light Show Pending
03/27/2006 2006V-0143 Pro Video Solutions, Inc./Laser Light Show Approved 05/04/2006
03/30/2006 2006P-0124 ViroPharma Incorporated/Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules Pending
03/30/2006 2006P-0144 Custopharm, Inc./delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA Interim Response 09/22/2006
03/31/2006 2006P-0145 Lachman Consultant Services, Inc./ANDA suitability for Gemcitabine Approved 08/22/2007
03/31/2006 2006P-0146 Coalition for Healthcare Communication/Request for Promulgation of an Amended Regulation for Pending
03/31/2006 2006P-0147 Lachman Consultant Services, Inc./Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld from sale for safety or efficacy reasons Withdrawn 06/28/2006
Top      
April      
04/05/2006 1981N-0033 The Procter & Gamble Company/Oral Health Care Drug Products for OTC Human Use Pending
04/05/2006 2006V-0153 Palomar Medical Technologies, Inc./Variance for Hair Removal System Approved 06/09/2006
04/07/2006 2006P-0137 Ocean Nutrition Canada, Ltd/Nutrient Content Claim for EPA and DHA omega-3 fatty acids Interim Response 11/27/2007
04/07/2006 2006P-0158 Citizens for Health/Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food Pending
04/10/2006 2006P-0151 Chemically Associated Neurological Disorders/Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants Denied 11/17/2006
04/10/2006 2006P-0154 Public Citizen/remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals) Denied 02/07/2007
04/11/2006 2006V-0155 Club Rabie, Inc/Laser Light Show Approved 06/26/2006
04/11/2006 2006V-0156 The Rhythm System/Projector for a Laser Light Show Pending
04/11/2006 2006P-0159 James Q. Maloy/Recommend changes to NIST Handbook 44 (through the NIST and NCWM), and the U.S. Pharmacopeia to reflect the required pharmacy quality control practices Denied 07/25/2006
04/13/2006 2006P-0160 Taro Research Institute/Request ANDA Suitability of Dichlorphenamide Tablets USP, 50 mg, Interim Response 10/04/2006
04/18/2006 2006V-0164 MGM Productions, Inc./Laser Light Show Approved 07/13/2006
04/18/2006 2006P-0165 Banner & Witcoff, Ltd./Initiate administrative proceedings for the purpose of investigating and enjoining the unlawful sale and distribution by International Tan Makers, Inc., of ultraviolet suntanning lamps that are misbr Answer 10/04/2006
04/20/2006 2006P-0167 Arnall Golden Gregory LLP/ANDA Suitability for Oxycodone and Acetaminophen drug product in an orally disintigrating formPending Pending
04/20/2006 2006P-0167 Arnall Golden Gregory LLP/ANDA Suitability for Oxycodone and Acetaminophen drug product in an orally disintigrating form Pending
04/24/2006 2006V-0171 Edge Innovations/Laser Light Show Pending
04/25/2006 2006P-0173 Wyeth Pharmaceuticals/Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product Interim Response 10/19/2006
04/26/2006 2006P-0174 NitroMed, Inc./FDA to determine that any drug is therapeutically equivalent or AB-rated to BiDil (isosorbide dinitrate and hydralazine hydrochloride Withdrawn 04/28/2006
04/26/2006 2006V-0153 Palomar Medical Technologis, Inc./Variance for Hair Removal System Pending
04/27/2006 2006V-0175 Haygood Entertainment/Laser Light Show Approved 06/01/2006
Top      
May      
05/01/2006 2006P-0177 Sicor Pharmaceuticals, Inc./Suitability for Methotrexate Withdrawn 02/20/2007
05/01/2006 2006P-0178 Public Citizen's Health Research Group/Immediately ban fluoroquinolone antibiotic gatifloxacin in humans Interim Response 10/27/2006
05/02/2006 2006P-0179 Y. Kim/Ban of Carcinogenic Potassium Bromate Interim Response 12/04/2006
05/04/2006 2006P-0186 Charles R. Nolan, M.D/Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg Interim Response 10/27/2006
05/05/2006 2006V-0188 Village Group International/Club Metropolis/Laser Light Show Approved 05/22/2006
05/08/2006 2006V-0192 New Life Church/Laser Light Show Approved 05/22/2006
05/09/2006 2006V-0194 Funzalosound/Laser Light Show Closed 05/09/2006
05/09/2006 2002V-0183 Funzalosound/Laser Light Show Pending
05/10/2006 2006P-0195 Rakoczy Molino Mazzochi Siwik LLP/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
Interim Response 11/02/2006
05/10/2006 2006P-0196 West-Ward Pharmaceutical, Corp./ANDA for Lithium Carbonate Tablets, 300 mg (NDA 016834) Withdrawn 08/11/2006
05/11/2006 2006P-0201 B. Braun Medical Inc./Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons Interim Response 11/02/2006
05/12/2006 2006P-0205 Rutgers, The State University Of New Jersey/Require Vitamin D be added to cereal-grain products Pending
05/15/2006 2006P-0207 Strides Inc./ANDA Suitability for Cetirizine Hydrochloride Soft Gelatin Capsules 5mg and 10mg Pending
05/15/2006 2006P-0208 Strides, Inc./Permit the filing of an ANDA for Loratadine Soft Gelatin Capsules 10mg Pending
05/16/2006 2006P-0209 Lachman Consultant Services, Inc./Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml Interim Response 11/13/2006
05/17/2006 2006P-0210 The International Center for Technology Assessment/Petition requesting FDA amend its regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically Interim Response 11/09/2006
05/17/2006 1978N-0038 The International Center for Technology Assessment/Sunscreen Drug Products Pending
05/17/2006 2006P-0212 Michael Patterson/Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent Denied 07/20/2007
05/17/2006 2006P-0213 Michael Patterson/enforce the single-use requirement for all Microkeratomes and their components used by Lasik Denied 07/20/2007
05/23/2006 2006V-0216 UniversalStudios Florida/Laser Light Show Approved 07/05/2006
05/23/2006 2006V-0217 Soundex Information Systems, Inc./Laser Light Show Pending
05/24/2006 2006P-0218 West-ward Pharmaceutical Corp./ To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension Interim Response 11/20/2006
05/26/2006 2006P-0223 State of Wisconsin Department of Justic/swith 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 because of Interim Response 11/20/2006
05/26/2006 2006P-0224 Pfizer Inc./Take appropriate remedial action against the apparent misbranding of generic azithromycin marketed by Pliva, Inc. Interim Response 11/20/2006
Top      
June      
06/02/2006 2006P-0093 ECO Animal Health/ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128- 409, Merial LTD., Pending
06/02/2006 2006V-0227 Kiamesha Lanes/Request for Laser Light Show Projector Approved 08/11/2006
06/06/2006 2006P-0230 Kamins Dermatologics, Inc./Abbrevation New Drug Application Suitability for Lidocaine Hydrochloride Pending
06/06/2006 2006P-0241 Zydus Pharmaceuticals Inc/Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy Pending
06/09/2006 2006P-0242 AstraZeneca LP (AstraZeneca)/Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules Interim Response 12/04/2006
06/09/2006 2001P-0075 FDA to Center for Reproductive Rights/Switch Status of Emergency Contraceptives from Rx to OTC Pending
06/09/2006 2006FL-0238 International Media and Cultures (IMAC)/Food Allergen Labeling Petition (FALP): Culture Media with Enzyme-Treated Soy Solids Pending
06/13/2006 2006V-0244 Cypress Gardens/Laser Light Show Approved 06/26/2006
06/13/2006 2006P-0245 Mylan Pharmaceuticals, Inc./Exclusivity Determination for Risperidone Interim Response 12/15/2006; Withdrawn 06/28/2007
06/13/2006 2006P-0249 Bayer HealthCare /Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution Interim Response 12/08/2006
06/15/2006 2006V-0248 Independence High-SpaceScience Tech Magnet/Laser Light Show Approved 06/26/2006
06/15/2006 2006P-0251 Maya F. Perrott/Label change or removal from the market of the psychotropic drug Depakote Denied 09/20/2006
06/16/2006 2006P-0243 ACH Food Companies, Inc./Qualified Health Claim: (QHC) : Corn oil and corn oil containing foods and heart disease Interim Response 06/16/2006; Answer 03/26/2007
06/16/2006 2006P-0253 AAC Consulting Group/ANDA Suitability for Loperamind Hydrochloride Pending
06/19/2006 2006P-0256 Number Not Used/See 78n-0038 CP18 Pending
06/19/2006 1978N-0038 Schering-Plough Consumer Healthcare/Sunscreen Drug Products Interim Response 12/08/2006
06/20/2006 2006P-0255 Orchid Healthcare (A Division of Orchid Chemicals & Pharmaceuticals Ltd)/discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons Interim Response 12/14/2006; Answer 03/28/2007
06/20/2006 2006V-0257 Bart Rocket Theatre/Laser Light Show Pending
06/20/2006 2006P-0258 Zydus Pharmaceuticals (USA) Inc./Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784 Pending
06/21/2006 2006P-0263 Sparhawk Laboratories, Inc/ANADA suitability for Neomycin Approved 09/06/2006
06/22/2006 2006P-0265 Lupin Pharmaceuticals, Inc./to permit an ANDA Suitability for Cefdinir Pending
06/26/2006 2006P-0267 Lachman Consultant Services, Inc./to permit an ANDASuitability for Dextroamphetamine Sulfate Tablets Approved 03/20/2007
06/26/2006 2006P-0271 Clinical and Laboratory Standards Institute/Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI. Approved 03/05/2007 in part and denied in part
06/27/2006 2006V-0269 Saginaw Spirit/Laser Light Show Approved 08/25/2006
06/27/2006 2006V-0270 Rocky Mount Children's Museum/Laser Light Show Approved 08/25/2006
Top      
July      
07/03/2006 2006P-0272 Beckloff Associates, Inc./ANDA Suitability for 0.9% Sodium Chloride Injection Approved 08/23/2007
07/03/2006 2006P-0273 Beckloff Associates/ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes Approved 08/22/2007
07/06/2006 2006P-0085 American Association of Neurological Surgeons/To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements Pending
07/12/2006 2006P-0280 Public Citizen Litigation Group/Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006 Withdrawn 07/27/2006
07/12/2006 2006P-0281 Camargo Pharmaceutical Services, LLC/Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet Closed 08/16/2007
07/14/2006 2006P-0285 Duramed Research, Inc./Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale Interim Response 01/12/2007
07/17/2006 2006P-0286 Lachman Consultant Services, Inc./Determine Whether Phoslo (calcium acetate) Capsules eq169 mg calcium have been voluntarily withdrawn from sale for safety or effcacy reasons. Withdrawn 08/28/2006
07/17/2006 2006P-0287 Lachman Consultant Services, Inc./determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons Closed 07/30/2007
07/19/2006 2006P-0288 Beckloff Associates/Permit an ANDA Suitability for Alprazolam Pending
07/19/2006 2006V-0289 Bliss Nashville LLC/Laser Light Show Approved 08/25/2006
07/24/2006 2006P-0290 Mylan Laboratories Inc./Risk Management Program for Fentanyl Products Interim Response 01/22/2007
07/24/2006 2006P-0299 Rothwell, Figg, Ernst & Manbeck, P.C./Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons Interim Response 01/22/2007; Answer 11/26/2007
07/25/2006 2006P-0291 Sicor Pharmaceuticals, Inc./Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons Interim Response 01/22/2007; Answer 11/26/2007
07/25/2006 2006P-0298 AAC Consulting Group/To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection) Interim Response 01/22/2007; Answer 11/26/2007
07/28/2006 2006P-0300 Lachman Consultant Services Inc./ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg Answer 03/20/2007
07/31/2006 2006P-0302 Beckloff Associates/Permit the filing of an ANDA Suitability for Sodium Chloride Injection Approved 08/22/2007
Top      
August      
08/02/2006 2006V-0304 Hart Entertainment/Laser Light Show Pending
08/02/2006 2006P-0305 Monosol Rx, LLC./Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg Pending
08/02/2006 2006P-0307 University of California/To amend 21CFR 201.17 regarding expiration dates Interim Response 01/25/2007
08/03/2006 2006P-0306 The States of Kansas, Minnesota, Vermont and Wisconsin/Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
Interim Response 01/30/2007
08/07/2006 2006P-0309 Frommer, Lawrence & Haug, LLP/ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials Interim Response 02/02/2007; Answer 11/26/2007
08/07/2006 2006P-0310 Peiser & Associates Inc./Compel the Agency to follow requirements of the Drug Listing Act of 1972 Interim Response 02/02/2007
08/07/2006 2006P-0311 Foley & Lardner LLP/Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories Interim Response 02/02/2007
08/07/2006 2006P-0313 Bayer Corporation/Removal of labeling for MediSense Precision Advanced Diabetes Management System Withdrawn 09/06/2006
08/08/2006 2006V-0317 Linden Laser Systems/Laser Light Show Pending
08/10/2006 2006A-0318 Ropes & Gray/Request for Advisory Opinion Concerning Orange Book Listing of Patents Interim Response 02/02/2007
08/11/2006 2006P-0319 Washington Legal Foundation/Regarding review of policies and practices of DDMAC and OCBQ to ensure compliance with first amendment and statutory mandate Interim Response 02/07/2007
08/17/2006 2006P-0334 Regeneration Technologies, Inc./Reclassification Petition fo Bone Heterografts Interim Response 10/25/2007
08/18/2006 2006V-0337 Blazer Laser Safety, Inc/Variance for Laser Product "Life Beam Extreme" Pending
08/18/2006 2006P-0316 Unilever United States, Inc/Health Claim: Phyposterols and Reduced Risk of Coronary Heart Disease Pending
08/22/2006 2006P-0346 National Women's Health Network/Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause Interim Response 02/12/2007
08/24/2006 2006P-0348 Clinical and Laboratory Standards Institute/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 Pending
08/28/2006 2006P-0364 J. Kulli, M.D./Reformulation of central nervous system (CNS) stimulant drugs Pending
08/29/2006 2006P-0360 Hospira Inc./Determine that the discontinued formulation of Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons Pending
08/29/2006 2006P-0359 Number not used/Number not used (see 2006P-0319) Pending
08/29/2006 2006P-0361 Rakoczy Molino Mazzochi Siwik, LLP/Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025% Withdrawn 11/14/2006
Top      
September      
09/05/2006 2006P-0365 Kerr Corporation/Urge FDA to Take Regulatory Action to Safeguard the Public from Violative Dental Devices Distributed by Five Companies, Including Devices Manufactured in Unregistered Facilities and Answer 01/08/2007
09/06/2006 2006P-0351 Diplomate of the American Board of Internal Medicine & Nephrology Fulbright Scholar in Medicine/Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions Interim Response
09/06/2006 2006P-0370 Public Citizen/Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD) Pending
09/07/2006 2006P-0369 Kirkpatrick & Lockhart Nicholson Graham LLP/ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05% Pending
09/08/2006 2006P-0371 Public Citizen's Health Research Group/Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States Pending
09/08/2006 2006P-0372 Lachman Consultant Services, Inc./Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons Interim Response 03/07/2007; Answer 05/16/2007; Closed 05/16/2007 LET 2 6/1/07
09/11/2006 2006V-0373 Griffith Observatory, (Oschin Planetarium)/Laser Light Show Pending
09/11/2006 2006P-0375 John D. Stephens, M.D./Banning of Urogender Test Withdrawn 10/12/2006
09/11/2006 2006P-0376 John D. Stephens, M.D./Banning of Acu-Gender Blood Test Withdrawn 10/12/2006
09/12/2006 2006V-0377 Evans & Sutherland Computer Corporation/Laser Light Show Pending
09/12/2006 2006P-0379 The George Washington University Medical Center/To urge the FDA 's prompt action to cancel the GRAS desgnation for diacetyl Interim Response 06/25/2007
09/15/2006 2006P-0387 Paddock Laboratories/Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA Pending
09/18/2006 2006V-0388 Martin Professional Inc./Projector for a Laser Light Show Pending
09/18/2006 2002F-0316 Food & Water Watch/Safe Use of Mix of Bacteriofages/Antimicrobial Agent Pending
09/19/2006 2006P-0390 Jerry Staton/Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing" Interim Response 03/16/2007
09/22/2006 2006P-0392 Valeant Pharmaceuticals International (Valeant)/ANDA for a Diazepam Rectal Gel that Relies on Diastat 5 mg/mL, 10 mg/2mL, 15 mg/3 mL or 20 mg/mL Interim Response 03/20/2007
09/27/2006 2006P-0394 Compassion Over Killing, Inc./Revise the labeling requirements for eggs sold in the United States Pending
09/27/2006 2006P-0395 Kendle International/To permit an ANDA Suitability for Metoprolol Tartrate Tablets Pending
09/28/2006 2006P-0393 Cargill, Incorporated/Health Claim Petition; Barley Betafiber and Cornary Heart Disease Pending
09/28/2006 2006P-0399 Beckloff Associates/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 Closed 07/30/2007
09/29/2006 2006P-0397 Lupin Pharmaceuticals, Inc./Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension Pending
09/29/2006 2006P-0398 Frommer Lawrence & Haug, LLP/Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml) Interim Response 03/20/2007
09/28/2006 2006P-0402 Washington Legal Foundation (WLF)/FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew) Pending
09/29/2006 2006V-0401 Superimaging Inc and AP Marketing Development/Laser Display Device Pending
Top      
October      
10/02/2006 2006P-0404 B. Braun Medical, Inc./Determine Whether Cefotan (Cefotetan Injection) has been Voluntarily Withdrawon from the Sale for Safety and Efficacy Reasons Interim Response 03/26/2007
10/03/2006 2006P-0403 B. Braun Medical Inc./Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957 Withdrawn 03/27/2007
10/03/2006 2006P-0405 UCB, Inc/Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions Interim Response 04/02/2007
10/05/2006 2006P-0406 Pfizer Inc./Take appropriate remedial action against the apparent misbranding of generic azithromycin for oral suspension marketed by Pliva, Inc. Interim Response 03/26/2007
10/10/2006 2006P-0410 MedImmune Oncology, Inc./Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information Interim Response 04/02/2007
10/12/2006 2006P-0415 Center for Food Safety/Petition Seeking Regulation of Cloned Animals Pending
10/16/2006 2006P-0417 Lachman Consultant Services, Inc./to permit an ANDA Suitability for Doxycycline Monohydrate Tablets Pending
10/18/2006 2001E-0213 Generamedix Pharmaceuticals, Inc./Angiomax, Patent Term Extension Application, No. 5,196,404Withdrawn 01/03/2007 Withdrawn 01/03/2007
10/18/2006 2006P-0422 KV Pharmaceutical Company/Refrain from approval of any ANDA for metoprolol succinate extended release 100 mg and 200 mg tablets subsequent to ANDA 76-640 from KV Pharmaceutical Denied 12/12/2007; Closed 12/12/2007
10/19/2006 2006FL-0384 The Solae Company/Food Allergen Labeling Petition (FALP): Soy lecithin when used as processing aids Pending
10/19/2006 2006P-0423 Pharmacists Planning Service, Inc. et al/Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products Pending
10/20/2006 2006V-0424 RPI Entertainment & Media Group/Projector for a Laser Light Show Pending
10/23/2006 2006P-0428 Boehringer Ingelheim Pharmaceuticals, Inc./Combivent (ipratropium bromide and albuterol sulfate) Interim Response 04/20/2007
10/24/2006 2004P-0349 CoMeD, Coalition for Mercury-Free Drugs/Action on Products containing added Mercury Answer 12/21/2006
10/24/2006 2006V-0429 The Den- DenNightClub/Projector for a Laser Light Show Pending
10/24/2006 2006P-0535 CoMed, Coalition for Mercury-Free Drugs/Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products Answer 03/28/2007
10/26/2006 2006P-0437 Mediscovery, Inc./To Permit the Filing of an ANDA Suitability Petition for Paclitaxel, USP. Pending
10/26/2006 2006P-0438 Olsson, Frank and Weeda, P.C./ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12% Pending
10/26/2006 2006P-0444 Schwarz Pharma, Inc./Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets Answer 12/06/2006
10/27/2006 2006V-0440 Hyperfomance Audio Productions/Laser Light Show Pending
10/27/2006 2007P-0085 Grocery Manufacturers Association /Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity Pending
10/30/2006 2006P-0442 Orchid Healthcare/Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via Interim Response 04/23/2007
10/30/2006 1995N-0294 Grocery Manufacturers Association/Quality/fill container; common or unusual name regulations Closed 02/22/2007 See Docket 2007P-0085
10/30/2006 2006V-0447 Electric Cowboy/Laser Light Show Pending
10/30/2006 2006V-0448 Zokku/Laser Light Show Pending
10/30/2006 2006V-0449 Electric Cowboy/Laser Light Show Pending
10/31/2006 2006P-0445 Regulus Pharmaceutical Consulting, Inc./Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons Interim Response 04/23/2007
Top      
November      
11/01/2006 2006P-0446 Taro Pharmaceuticals USA, Inc./ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg Closed 07/30/2007
11/02/2006 2006P-0450 Pfizer Inc/Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
Pending
11/13/2006 2006P-0461 B. Braum NMedical, Inc./To Permit the Filing of an ANDA Suitability for Cefepime for Injection Pending
11/13/2006 2006P-0462 Lachman Consultant Services, Inc./Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe Pending
11/20/2006 2006P-0469 Strides Inc./Declare that a new drug application for Ibuprofen Potassium 200 mg Phenylephine Hydrochloride 10 mg Capsules is suitable for submission as an Abbreviated New Drug Application, pursuant to 21 CFR 314.9 Pending
11/20/2006 2006V-0470 Club MO Lasers/Laser Light Show Projector Pending
11/20/2006 2006P-0471 Center for Science in the Public Interest/Issue standards and regulations to help ensure the safe productions of fresh fruits and vegetable Pending
11/22/2006 2006V-0474 Palomar Medical Technologies, Inc./Variance for the Poalomar Lux1540 handpiece Pending
11/28/2006 2006P-0477 King & Spalding LLP/ANDA for potassium chloride oral solution drug products in strengths of 10% and 5% Pending
11/29/2006 2006P-0481 Actavis Totowa, LLC/ANDA Suitability for Oxycodone Hydrochloride Capsules, 5 mg Pending
11/29/2006 2006V-0482 Griffin Behm/Laser Light Show Pending
11/29/2006 2006P-0484 M. McDole/Change the indication for Stimulant Medications for the Treatment of Mental Diseases Denied 05/25/2007
11/29/2006 2006V-0485 N9NE Group dba Moon Bar/Projector for a Laser Light Show Approved 12/12/2006
Top      
December      
12/01/2006 2006P-0491 Kirkpatrick & Lockhart Nicholson Graham LLP/make a determination that the withdrawal of the Reference Listed Drug (RLD), Psorcon E (diflorasone diacetate oin tment) Emollient , Ointment, 0.05%, was not for safety or effectiveness reasons. Interim Response 05/25/2007
12/04/2006 2006P-0496 Vintage Pharmaceuticals, LLC/Determine whether Sulfamethoxazole, Trimethoprim, and Phenazopyride HCI, have been voluntarily withdrawn or withheld for safety or efficacy reasons Interim Response 06/04/2007
12/05/2006 2005P-0383 Savient Pharmaceuticals Inc/refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008. Pending
12/05/2006 2006P-0498 Center for Science in the Public Interest (CSPI)/Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods Interim Response 06/01/2007
12/05/2006 2006V-0499 Des Monies Astronomical Society, Inc./Hand Held Portable Green Laser Module Pending
12/07/2006 2006P-0503 Lachman Consultant Services, Inc./ANDA Suitability for Propoxyphene Napsylate and Acetaminophen Pending
12/08/2006 2006P-0487 Cargill/Health Claim Petition: Isomaltulose and Dental Caries Interim Response 12/08/2006
12/08/2006 2006P-0505 Lachman Consultant Services, Inc/ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg Pending
12/08/2006 2006V-0509 LFI International/Laser Light Show Interim Response 12/08/2006
12/11/2006 2006P-0506 Center for Science in the Public Interest/Request that the FDA announce an Advance Notice of Proposed Rulemaking regarding the use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods. Closed 12/19/2006 Duplicate of 2006P-0498
12/11/2006 2006P-0507 Sicor Pharmaceuticals, Inc./to permit an ANDA Suitability for Methotrexate Injection Pending
12/11/2006 2006P-0508 Charles E. Weber/Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status Interim Response 06/04/2007
12/11/2006 2006P-0511 Kleinfeld, Kaplan and Becker, LLP/Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822 Pending
12/13/2006 2006P-0510 Lachman Consultant Services, Inc./ANDA Suitability for Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg Tablets Pending
12/14/2006 2006P-0513 Caraco Pharmaceutical Laboratories, Ltd./Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness Pending
12/18/2006 2006P-0518 Michael Patterson, Ph.D., BSEE/Stop all approvals of medical devices and their components used for LASIK or place a moratorium on their use Denied 07/20/2007
12/18/2006 2006P-0519 Michael Patterson, Ph.D., BSEE/Stop all approvals of medical devices used for implantable lens implants including, but not limited to Phakic IOLs (PIOLs) and Collamar Lenses or to place a moratorium on their use Denied 07/20/2007
12/18/2006 2006P-0520 SICOR Pharmaceuticals, Inc./Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719) Pending
12/18/2006 2006V-0521 Mountain High Resort/Laser Light Show Pending
12/18/2006 2006P-0522 Endo Pharmaceuticals Inc/Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD Pending
12/20/2006 2006P-0523 Sanofi-aventis US LLP/Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing Pending
12/20/2006 2006P-0524 E. Tanghetti, MD/Withdrawal of Approval of and recall all available stock of Ziana Pending
12/22/2006 2006P-0534 King and Spalding, LLP/ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg Approved 08/22/2007
12/27/2006 2006P-0533 King & Spalding LLP/ANDA Suitability for Sterile Vancomycin Hydrochloride USP, 750 mg Approved 08/22/2007
12/28/2006 2006P-0536 Vaccine For All LLC/Amend 21 C.F.R. 312. promotion and charging for investigational drugs re: pandemic vaccine  
Top