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Regulatory Information
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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Consultant Services, Inc./Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21- 360), has been voluntarily withdrawn for safety or effectiveness reasons |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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 | |
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