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U.S. Department of Health and Human Services

Regulatory Information

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2007 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 Dockets No. Name of Petitioner/Subject Matter Disposition
January      
01/04/2007 2007P-0003 Pharmaceutical Scientist Inc./Issue guidelines on Risk-Based Bioequivalence Testing Pending
01/05/2007 2007P-0004 Dean Andrew Kantis/Take steps to insure the safey of Americans regarding th misues of Lasik Pending
01/08/2007 2007P-0008 Vaccine for All LLC/Create a new policy to achieve expanded and accelerated development and production of pre-pandemic and pandemic vaccine Pending
01/16/2007 2007P-0022 Lachman Consultant Services, Inc./ANDA Suitability Petition for Oral Transmucosal Fentanyl Citrate Pending
01/16/2007 2007P-0023 Victor L. Yu, M.D./Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute Pending
01/17/2007 2007P-0028 Lachman Consultant Services, Inc/Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons Pending
01/22/2007 2007P-0030 Lachman Consultant Services, Inc./ANDA Suitability for Acetaminophen 400 mg, Butalbital 50 mg and Caffeine 40 mg Capsules Pending
01/23/2007 2007P-0033 Ellen M. Ashworth/Amend the Nutrition Facts label on food products as it relates to trans fats. Pending
01/23/2007 2007P-0034 JRRapoza Associates, Inc./To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness Pending
01/29/2007 2007P-0037 Lachman Consultant Services, Inc./Declare that Loratadine Orally-Dissolving Strips, 5mg and 10mg, for an abbreviated new drug application (ANDA) Pending
01/30/2007 2007V-0039 Lasersmith Light Show Systems, LLC/Laser Light Show Pending
01/31/2007 2007P-0042 Lachman Consultant Services, Inc./ANDA Suitability for Zolpidem Tartrate Orally-Dissolving Strips Pending
Top      
February      
02/01/2007 2007P-0043 Lachman Consultant Services, Inc. /ANDA Suitability for Ondansetron Orally-Dissolving Strips Pending
02/06/2007 2007P-0044 Public Citizen's Health Research Group/Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis Pending
02/07/2007 2007P-0047 University of Florida/Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants Pending
02/08/2007 2007V-0048 Baylor University/Laser Light Show Pending
02/09/2007 2007P-0052 West-Ward Pharmaceutical Corp./determine whether a listed drug(Brethine) that has been voluntarily shortened from distribution and sale was shortened for reasons other than for safety or effectiveness reasons Pending
02/12/2007 2007V-0054 Daytona Beach Planetarium/Laser Light Show Pending
02/12/2007 2007V-0056 Heritage Planetarium/Laser Light Show Pending
02/20/2007 2007P-0059 Cancer Prevention Coalition et al/Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH) Pending
02/20/2007 2007P-0060 West-Ward Pharmaceutical Corp./ANDA Suitability for Hydrocortisone Tablets USP, 10 mg, (CORTEF) and Determine if CORTEF was Withdrawn for Safety or Efficacy Reasons Pending
02/21/2007 2007P-0062 Regulus Pharmaceutical Consulting, Inc./Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy ReaClosed 11/26/2007 Closed 11/26/2007
02/22/2007 2007V-0063 Sabeus, Inc./Variance for Alternate Means of Handling Interlocks - Sabeus AG-1 Laser System Pending
02/22/2007 2007P-0065 Pharmacists Planning Service, Inc./To increase print size of direct-to-consumer advertisements Pending
02/27/2007 2007V-0067 Aqua Night Club/Laser Light Show Pending
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March      
03/01/2007 2007P-0070 Charles E. Weber/Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water Interim Response 08/23/2007
03/01/2007 2007P-0071 Lachman Consultant Services, Inc./ANDA Suitability for Bisoprolol Fumarate and Hydrochlorothiazide Tablets Pending
03/01/2007 2007P-0072 Lachmman Consultant Services, Inc. /ANDA suitability for Metoprolol Tartrate Tablets Pending
03/01/2007 2007P-0074 Baltimore City Health Department et al/Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use Pending
03/01/2007 2007V-0075 ARJAY-ELLIS LLC/Laser Light Show Pending
03/05/2007 2007P-0079 David K. Richardson/To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry Pending
03/07/2007 2005H-0271 TMJ Implants, Inc., Robert W. Christensen, and Maureen Mooney/Civil Money Penalty: TMJ Implants, Inc. Pending
03/09/2007 2007V-0081 Fusion Laser Light Show/Laser Light Show Approved 03/27/2007
03/09/3007 2007V-0082 Information Database Solutions/Laser Light Show Approved 03/27/2007
03/12/2007 2007A-0087 WileyRein LLP/Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling Pending
03/12/2007 2007V-0088 Platinum Graphics/Projector for a Laser Light Show Pending
03/13/2007 2007P-0093 Perdue Pharma L.P./Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug Interim Response 09/07/2007
03/13/2007 2007V-0095 Number not used/Number not used Pending
03/14/2007 2007P-0094 Greenberg Traurig LLP/Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter Interim Response 09/07/2007
03/14/2007 2007V-0102 Number not used/Number not used Pending
03/14/2007 2002V-0347 Technological Artisans/Laser light show Approved 03/27/2007
03/15/2007 2007P-0096 Jennifer McGinn/Revoke 21 C.F.R. 165.110(a)(2)(vi), the rule regulating the labeling of bottled water sources Pending
03/15/2007 2007P-0097 Issue a new regulation wine product the composition of wine, water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designation Pending
03/15/2007 2007P-0100 JR Rapoza Associates, Inc./Abbreviated New Drug Application (ANDA) filing of Ciprofloxacin Hydrochloride Capsules, 100 mg, 250 mg, and 750 mg Pending
03/20/2007 2007P-0103 Keller And Heckman LLP/ANDA Suitability for Carvedilol Phosphate Extended-Release Tablets Pending
03/22/2007 2007P-0110 Pfizer Inc/To enforce pediatric exclusivity rights for amlodipine Denied 05/18/2007
03/22/2007 2007P-0111 Pfizer Inc./Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity Denied 05/18/2007
03/23/2007 2007P-0112 Three-Laboratory Consortium/Stay the implementation of recommendations currently being provided by CDER staff to companies concerning conduct of clinical trials and proposed statistical analyses for the efficacy requirements of Pending
03/26/2007 2006P-0113 B Braun Medical, Inc./ANDA Suitability for 15% Amino Acid Injection Product Pending
03/26/2007 2006P-0116 Mylan Pharmaceuticals Inc./Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007 Pending
03/27/2007 2007P-0119 Lachman Consulant Services, Inc. /ANDA Suitability for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup Pending
03/27/2007 2007P-0134 Lachman Consulting Services Inc./ANDA Suitability for Hydrocodone Bitrartrate and Homatropine Methylbroomide Tablets, 2.5 mg / 0.75 mg Pending
03/29/2007 2007P-0124 Olsson, Frank And Weeda, P. C./ANDA Suitability for clindamycin phosphate foam (non-aerosol), 1% Pending
03/30/2007 2007P-0126 PFI LLC/Amend Existing Regulation for Strength from 4.0-90 mci/mL to 0.0-475 mci/mL Concerning NDA 20-306 (Fludeoxyglucose F 18 Injection) Pending
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April      
04/02/2007 2007P-0127 Ortho-McNeil, Inc./Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER Pending
04/03/2007 2007V-0128 Sunset Productions/Laser Light Show Pending
04/03/2007 2007P-0129 C Smith/To revoke the food processing permit granted to Bella Cucina Artful Food Pending
04/04/2007 2007P-0130 Zydus Pharmaceuticals USA, Inc./Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate Withdrawn 09/28/2007
04/10/2007 1975N-0183F Century Pharmaceuticals, Inc. (CPI)/Topical Antimicrobial Drug Products For OTC Human Use - First Aid Pending
04/10/2007 2007P-0140 Warner Chilcott Inc./Stay final approval and/or effective date of final approval of any 0.4. mg Norethindrone and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs unless there is pharmaceutical e Interim Response 10/05/2007
04/10/2007 2007V-0141 Laser Design Productions/Laser Light Show Pending
04/11/2007 1975N-0183H Century Pharmaceuticals, Inc./Health-Care Antiseptic Drug Products for OTC Human Use Pending
04/12/2007 1996V-0138 FDA/CDRH to Strictly FX LLC/Laser Light Show Pending
04/12/2007 2007P-0142 Acorda Therapeutics, Inc./Incorporate the full proprietary name Zanaflex Capsules, intead of the truncated form of the name Zanaflex Interim Response 10/04/2007
04/13/2007 2007P-0147 Sara Lee Corporation/Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service Pending
04/19/2007 2007P-0159 Alcon Research, Ltd./Take prompt enforecment actions due to the clearly defined public health risk of Toxic Anterior Segment Syndrome (TASS) and secure the removal of illegally marketed unapproved ophthalmic Balanced Salt Pending
04/20/2007 2007P-0157 Medicis/Request for Stay Granting Provisional Market Exclusivity and Patent Listing for Ziana Pending
04/20/2007 2007P-0158 Medicis/Patent Listing and Market Exclusivity for Combination Drugs When One Component is a pre- 1997 Antibiotic Ingredient Pending
04/23/2007 2007N-0120 Barnev Ltd./Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System Pending
04/24/2007 2007A-0164 AFrame Digital, Inc/Request for Advisory Opinion for an Mobilecare Monitor System 2100 Pending
04/27/2007 2007P-0167 Akorn-Strides, LLC/Permit filing of an ANDA for Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL Injectioon, 10 mg/mL -- 10 mL fill size Pending
04/27/2007 2007V-0170 Moonlight Productions/Projector for a Laser Light Show Pending
04/27/2007 2007P-0171 Mylan Laboratories, Inc./Not delist U.S. patent 4,879,303 (the 303 patent) for Norvasc amlodipine besylate product Pending
Top      
May      
05/01/2007 2007P-0172 Aurobindo Pharmaceuticals Ltd./Determine whether Minocycline Hydrocholoride, Minocin Capsules EQ 75 mg Base Manufactures by Triax Pharmaceuticals, Ltd., has been valintarily withdrawn from sale for safety or efficacynreasons. Pending
05/01/2007 2007P-0178 Association of Medical Device Reprocessors/Take action to subject certain cardiac surgery devices to premarket notification (510(k) requirements Pending
*05/02/2007 2007P-0175 Norbrook, Inc./ANADA Suitability for ivermectin/pyrantel pamoate chewable tablets Closed 11/27/2007
05/02/2007 2007P-0093 Purdue Pharma L.P./Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug Pending
05/02/2007 2007P-0127 Purdue Pharma L.P./Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER Pending
05/03/2007 2007P-0177 Norbrook Laboratories Limited/ANADA Suitability for generic new animal drug meloxicam which differs from the pioneer product, Metacam 1.5 mg/mL Oral Suspension Pending
05/04/2007 2007V-0181 Apollo Instruments, Inc./Interlock for Laser Modules and Beam Attenuator Pending
05/07/2007 2007P-0187 J Shingara/Requirements of Iodized Salt on Ingredient Labels Pending
05/09/2007 2007N-0136 Agendia BV/Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis Pending
05/11/2007 2007P-0194 Lachman Consultant Services, Inc./to permit the filingof an abbreviated new drug application (ANDA) for Acetaminophen, Butalbital, Caffeine and Hydrocodone Bitartrate Capsules Pending
05/14/2007 2007V-0196 LaserMax/Laser Gunsight Pending
05/15/2007 2007V-0199 Classic Sound machine/Laser Display Device Pending
05/18/2007 2007P-0203 Orgenus Pharma, Inc./Abbreviated New Drug Application (ANDA) Suitability for Memantine Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg Pending
05/21/2007 2007P-0205 Emil A. Tanghetti, M.D./Withdraw approval of and recall all available stock of Ziana or require the immediate initiation of long-term safety studies evaluating the incidence and prevalence of antibiotic resistance associated Pending
05/22/2007 2007P-0209 Sandoz Inc./Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extendend-release tablets (metoprolol) 50 mg Pending
05/22/2007 2007P-0210 HiFi DNA Tech, LLC/Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C Pending
05/23/2007 2007P-0211 Sheppard Mullin Richter & Hampton LLP/Determine that the listed drugs, oxycodone hydrochloride extended release tablets, 15 mg, 30 mg, and 60 mg, were voluntarily withdrawn by Purdue Pharma LP, for reasonsother than safety Pending
05/24/2007 2007P-0214 Sandoz, Inc./ANDA Suitability for Cefazolin Injection, USP 2 g Vials Pending
05/25/2007 2003V-0179 Musititlan Entertainment/Laser Light Show Pending
05/29/2007 1977N-0094 Brian Kaplan, M.D./OTC Internal Analgesic, Antipyretic & Antirheumatic Products Pending
05/30/2007 2007P-0216 Ben Venue Laboratories, Inc./Determine that an additional dosage of Deferoxamine Mesylate for Injection, USP is suitable for an abbreviated new drug application (ANDA) Pending
05/30/2007 1978N-0038 Office of the Connecticut Attorney General/Sunscreen Drug Products Pending
Top      
June      
06/01/2007 2005V-0145 Disneyland Resort/Laser Light Show Pending
06/07/2007 2007V-0222 Tempest International LLC/Projector for a Laser Light Show Approved 08/14/2007
06/07/2007 2007P-0224 Sanofi Aventis U.S. Inc./ANDA Suitability Petition for NDA 21-774 Ambien CR (Zolpidem tartrate) Pending
06/07/2007 2004P-0006 Kleinfeld, Kaplan and Becker, LLP/Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release Closed 06/07/2007
*06/07/2007 2007P-0232 Kleinfeld, Kaplan and Becker, LLP/Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release Interim Response 12/06/2007
06/08/2007 2007P-0226 Lachman Consultant Services, Inc./to permit an ANDA suitability for Donepezil Hydrochloride Orally Dissolving Film Stripps, 5 mg and 10 mg Pending
06/08/2007 2000D-0109 Clinical and Laboratory Standards Institute/Assessment of Antimicrobial Susceptibility Devices Pending
*06/08/2007 2007P-0237 Clinical and Laboratory Standards Institute/Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility
Interim Response 12/06/2007
06/11/2007 2003V-0550 Whatergy, Inc./Laser Light Show Pending
06/12/2007 2005V-0266 Stone Mountain Media/Laser Light Show Pending
*06/15/2007 2007P-0235 Compassion Over Killing & Peen Law Animal Law Project-University of Pennsylvania Law School/Change the labeling requirements for eggs sold in the United States
Interim Response 12/13/2007
06/19/2007 2007P-0239 Lachman Consultant Services, Inc./ANDA Suitability for Escitalopram Oxalate Orally Dissolving Film Strips, 5 mg, 10 mg and 20 mg
Pending
06/19/2007 2007V-0242 Prismatic Magic LLC/Variance for a projector for a laser light show Pending
06/19/2007 2007V-0243 Fyxx Enteraiment/Laser Light Show Pending
06/20/2007 2007P-0247 Lachman Consultant Services, Inc./ANDA Suitability for Diflunisal Tablets USP, 375 mg Pending
06/21/2007 2007V-0248 Slick Productions/Laser Light Show Display Pending
06/21/2007 2007FL-0236 The Solae Company/Food Allergen Labeling Petition (FALP): Soy lecithin when used as processing aids
Pending
*06/22/2007 2007P-0250 HARMD (Helping America Reduce Methadone Deaths)/Enact stricter guidelines in prescribing methadone for any reason
Interim Response 12/10/2007
*06/22/2007 2007P-0251 Public Citizen Health Research Group/Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, includ
Interim Response 12/10/2007
*06/22/2007 2007A-0261 Ropes & Grays LLP/Advisory Opinion request to list certian types of patents in the Orange Book Interim Response 12/17/2007
06/25/2007 2007V-0258 Neptec Design Group/Laser Camera System Pending
Top      
July      
07/03/2007 2007P-0273 Clinical and Laboratory Standards Institute/Request that CDER update the official drug labels for penicillin G potassium and penicillin Gsodium for injection Pending
*07/03/2007 2007P-0274 FDA/DDM to Clinical and Laboratory Standards Institute/Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin Interim Response 12/06/2007
07/09/2007 2006N-0362 Ferrosan A/S/General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device Pending
07/09/2007 2007V-0271 Margaret C. Woodson Planetarium/Laser Light Show Pending
07/09/2007 2007P-0272 Lachman Consultant Services, Inc./ANDA Suitability for Acetaminophen, Caffeine and Dihydrocodeine Tablets, 534.6 mg/45 mg/24 mg Pending
07/10/2007 2007P-0275 Lachman Consultant Services, Inc/To permit an ANDA Suitability for Nabumetone Tablets 1000 mg Pending
07/13/2007 2007V-0281 P.A.W.N. LLC/Projector for a Laser Light Show Pending
07/13/2007 2007P-0282 Dawn Densmore/Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20% Pending
07/13/2007 2007P-0283 Purdue Pharma L.P./Take actions with respect to NDAs and ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients Pending
07/16/2007 1999V-4395 Lightwave International, Inc/Laser Light Show Pending
07/23/2007 2007P-0293 Emcure Pharmaceuticals USA, Inc. /To permit an ANDA Suitability for Fenoprofen Calcium Capsules, 400 mg Pending
07/24/2007 2007P-0295 Regulus Pharmaceutical Consulting, Inc./Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued Pending
07/24/2007 2006P-0123 Mylan Technologies Inc./Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products Pending
07/25/2007 1996N-0417 American Herbal Products Association/CGMP in Mfg. Packing or Holding Dietary Supplements Pending
07/27/2007 2007P-0296 Mutual Pharmaceutical Co./Request that the FDA requires labeling changes for Skelaxin (active ingredient metaxalone) as set forth in the proposed revised packaging insert Pending
07/30/2007 2007P-0297 CareToLive/Request to reconsider the failure to approve Provenge Pending
07/30/2007 2007P-0302 Axcan Scandipharm, Inc./Require all manufacturers of a generic verision of CANASA (mesalamine) rectal suppositories to perform an adequate and well-controlled clinical safety and effectiveness trial Pending
07/31/2007 2007P-0300 B Braun Medical, Inc./ANDA Suitability for 15% Amino Acid Injection product in a package size not covered under the Reference Listed Druin a package size not covered under the Reference Listed Drug's (RLD) application Pending
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August      
*08/01/2007 2007P-0301 Immunotec, Inc./Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Peition Denied 10/31/2007
08/03/2007 2007P-0307 Lachman Consultant Services, Inc./ANDA Suitability for Hydrocodone Bitartrate and Homatropine Methylbromide Capsules 5 mg / 1.5 mg Pending
08/08/2007 2007V-0312 Catawba Science Center/Laser Display Device Pending
08/08/2007 2007V-0314 Williamsville Space Lab Planetium/Laser Light Show Pending
08/08/2007 2007V-0315 Hollywood Pro Lighting/Projector for a Laser Light Show Pending
08/08/2007 2007P-0316 Teva Pharmaceuticals USA/Risperdal (Risperidone) Tablets Pending
08/10/2007 2007P-0318 Cornerstone Regulatory/Declare that, Glucagon Hydrochloride (Glucagon) for Injection is suitable for an abbreviated new drug application (ANDA) Pending
08/13/2007 2007V-0319 Geller/Laser Light Show Pending
08/14/2007 2007P-0210 HiFi DNA Tech, LLC/Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C Pending
08/14/2007 2007P-0320 Health Care Without Harm/Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers Pending
08/14/2007 2007P-0322 Takeda Pharmaceuticals North America/Approval of Generic Versions of Pioglitazone Hydrochloride with Less than Complete Labeling Pending
08/20/2007 2007P-0326 AAIPharma, Inc. /Determine Whether Sanorex (Mazindol) Tablets, 1 and 2 mg, (NDA 17-247), by Novartis, Have Been Voluntarily Withdrawn or Withheld From Sale for Safety or Efficacyr Reasons Pending
08/24/2007 2007P-0331 Coalition for Mercury-Free Drugs/Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic Pending
08/24/2007 2007A-0332 Alston & Bird LLP/Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products Pending
08/28/2007 2007P-0334 Anil K. Mandal, M.D./Prohibit the use of low molecular weight heparin in patients with acute or chronic renal failure and in elderly subjects more than 65 years of age Pending
08/28/2007 2007V-0335 Dodd Technologies, Inc./Projector for a Laser Light Show Pending
Top      
September      
09/04/2007 2007P-0346 Thunder Bay Seafood Co., Inc./Stay the effective date of any possible refusal of AQZ-0250569-4 and AQZ-0250573-6 as a consequence of the denial by Los Angeles District of the FD-766 Pending
09/04/2007 2007P-0333 Dave Wayne/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
09/05/2007 2007P-0336 Matrix Laboratories, Inc./To permit an ANDA Suitability for RitonavirTablets, 100 mg Pending
09/05/2007 2007P-0333 Dwight G. Castle/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
09/05/2007 2007P-0345 International Pacific LLC d.b.a. Pacific Supreme/Stay the effective date of any possible refusal of Entry AQZ-0250069-5 as consequence of the denial by Los Angeles District of the FD-766 Pending
09/07/2007 2007V-0338 Palomar Medical Technologies, Inc./Variance for an Alternate Beam Attenuator Pending
09/12/2007 2007V-0349 Amanda Kushner/Laser Light Show Pending
09/13/2007 2007V-0339 Top Shelf Club/Laser Light Show Pending
09/13/2007 2007V-0340 Eastside Entertainment LLC/Laser Light Show Pending
09/13/2007 2007P-0341 Sun Pharmaceuticals, Ltd./Determine whether Zometa (Zoledronic Acid for Injection) has been Withdrawn for Safety or Effectiveness Reasons Pending
09/13/2007 2007P-0333 John Gilbert/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
09/17/2007 2007P-0333 Michael E. Masterman/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
09/17/2007 2007P-0333 John W. Shaw/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
09/18/2007 2007V-0350 Vestar Temple Market Place/Laser Light Show Display Pending
09/18/2007 2007P-0333 Rebecca Gilbert/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
09/18/2007 2007P-0351 Engal & Novitt, LLP/Address the potential drug-safety-and efficacy-related issues that are expected to arise in connection with the issuance of final approvals for at least seven (7) tentatively-approved applications see Pending
09/18/2007 2007P-0351 Engel & Novitt, LLP/Address the potential drug-safety-and efficacy-related issues that are expected to arise in connection with the issuance of final approvals for at least seven (7) tentatively-approved applications see Pending
09/19/2007 2007P-0369 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251860-6 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension Pending
09/19/2007 2007P-0370 Thunder Bay Seafood Co., Inc/Stay the effective date of any refusal of Entry AQZ-0251196-5 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the Pending
09/19/2007 2007P-0371 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251197-3 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/19/2007 2007P-0372 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251198-1 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/19/2007 2007P-0373 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251199-9 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/19/2007 2007P-0374 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251206-2 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/19/2007 2007P-0375 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251212-0 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/19/2007 2007P-0376 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251619-6 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/19/2007 2007P-0377 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251620-4 as a Pending
09/19/2007 2007P-0378 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0251861-4 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re Pending
09/20/2007 2007P-0352 HellerEhrman LLP/FDA withdrawn the commercial marketing authorization for oral sodium phosphate (OSP) products for bowel cleansing and reclassify all OSP products for bowel cleansing as prescription only medicines Pending
09/21/2007 2007P-0354 Celgene Corporation/Refrain from approving Any Application for a Generic Thalidomide Product Pending
09/24/2007 2007P-0358 Astellas Pharma U. S., Inc./Ensure the Safe and Effective Use of Orally Administered Immunosuppressant Drugs That are Used in the Transplant Population and are Characterized by a Narrow Therapeutic Index Pending
09/25/2007 2007V-0360 Bel Entertainment LLC/Laser Light Show Pending
09/26/2007 2007P-0361 King Pharmaceuticals, Inc./Approve Abbreviated New Drug Applications (ANDA's) and 505 (b)(2) applications that reference drug products containing auto-injectors-- and to make therapeutic equivalence designations----only in acco Pending
09/27/2007 2007P-0333 Lachman Consultant Services, Inc./To determine whether Namenda Tablets 15 mg and 20 mg (approved under NDA 21-487 owned by Forest Laboratories) were Voluntarily withdrawn from sale for reasons related to safety efficacy Pending
09/27/2007 2007P-0362 Lachman Consultant Services, Inc./To determine whether Namenda Tablets 15 mg and 20 mg (approved under NDA 21-487 owned by Forest Laboratories) were Voluntarily withdrawn from sale for reasons related to safety efficacy Pending
09/28/2007 2007P-0379 Thunder Bay Seafood Co., Inc./Stay the effective date of any refusal of Entry AQZ-0252410-9 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 30-day extension of time to supply the r Pending
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October      
10/03/2007 2007V-0383 Net Tek/Laser Light Show Device Pending
10/03/2007 2007V-0384 Number not Used/Number not used Pending
10/03/2007 2007P-0385 Ralph D. Childs/Electronic Product Radiation Control for Medical Devices Pending
10/05/2007 1981N-0033 Beutlich Pharmaceuticals LP/Oral Health Care Drug Products for OTC Human Use Pending
10/11/2007 2007P-0333 Michael F. Clark/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
10/15/2007 2007P-0399 Purdue Pharma L.P. and Rhodes Technologies/Adopt, announce, and implement a consistent, CDER- wide standard for the acceptable level of 14-hydroxycodeinone impurity in oxycodone HCI API approved by FDA for use in drug products Pending
10/15/2007 2007P-0399 Purdue Pharma L.P. and Rhodes Technologies /Adopt, announce, and implement a consistent, CDER-wide standard for the acceptable level of 14-hydroxycodeinone impurity in oxycodone HCI API approved by FDA for use in drug products Pending
10/16/2007 2007V-0397 Chevy Chase Productions/Laser Light Show Pending
10/16/2007 2007P-0398 Lachman Consultant Services, Inc./ANDA Suitability for Zaleplon Capsules, 7.5 mg Pending
10/16/2007 2007P-0400 Richard Sauerheber, Ph.D./Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion Pending
10/17/2007 2007P-0402 Fuerst, Humphrey, Ittleman, PL/Take regulatory enforcement action to protect consumers from Pending
10/18/2007 2007P-0403 VCU School of Medicine /ANDA Suitability for Levomethadyl Acetate HCI 10mg 20mg and 40mg Tablets Pending
10/18/2007 2007P-0333 Robert E. Parks/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
10/19/2007 2007P-0404 Lupin Pharmaceuticals, Inc./Declare that Cefixime for Oral Suspension, 100 mg/mL, is suitable for submission as an ANDA Pending
10/22/2007 2007P-0405 Thunder Bay Seafood Company/Stay the effective date of any possible refusal of entry AQZ- 0251621-2 Pending
*10/22/2007 2007P-0406 Thunder Bay Seafood Company/Stay the effective date any possible refusal of entry AQZ-0251860-6 Pending
*10/22/2007 2007P-0435 Thunder Bay Seafood Company/Stay the effective date of any possible refusal of entry AQZ- 0251619-6 Pending
*10/22/2007 2007P-0436 Thunder Bay Seafood Company/Stay the effective date of any possible refusal of entry 595-4331551-5 Pending
10/23/2007 2007P-0407 Matrix Laboratories, Inc./To permit the filling of a Abbreiated new drug application (ANDA) for Abacavir Sulfate Tablets 60 mg Pending
10/24/2007 2007P-0414 Cobalt Laboratories Inc., and Cobalt Pharmaceuticals Inc.,/Stay approval of any and all subsequent abbreviated new drug applications (ANDAs) for Acarbose Tablets 25mg, 50 mg, and 100 mg Pending
*10/25/2007 2007P-0421 Thunder Bay Seafood Co., Inc./Stay the effective date of any possible refusal of entry AQZ-0251620-4 Pending
*10/26/2007 2007P-0420 The Alliance Against Alveolar Soft Part Sarcoma and The Sarcoma Foundation of America/Issue a guidance document for the accelerated approval of drugs and biologics that are intended to treat rare cancers, including alveolar soft part sarcom Pending
*10/29/2007 2007P-0416 Prolacta Bioscience/To promulgate regulations defining human milk to be a food, and for the conditation of neonatal prematurity, a medical food Pending
*10/29/2007 2007P-0418 Solvay Pharmaceuticals, Inc./Prevention of False and Misleading Labeling and Promotion of Safe and Efficacious Use of Dronabinol
Pending
*10/30/2007 2007P-0428 King and Spalding LLP/Abbreviated New Drug Application (ANDA) suitable for diclofenac sodium and misoprostol, in respective combinations of 50 mg/200 mcg and 75 mg/200 mcg Pending
*10/30/2007 2007P-0455 Sidelines National Support Network/Revoke the Orphan Drug designation for Gestiva Pending
*10/31/2007 2007P-0429 The National Center on Addiction and Substance Abuse at Columbia University/Take action to strengthen FDA regulation of controlled prescription drugs, and help minimize the risks of diversion of controlled prescription drugs, by issuing new rules Pending
*10/31/2007 2007P-0434 King Pharmaceuticals, Inc/To take the actions refrain from approving a recombinant thrombin biologies license application BLA Pending
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November      
*11/01/2007 2007P-0431 Epidemiology and Community Health vcu School of Medicine/Determine whether levomethadyl acetate HCI (Orlaam) NDA-20-315 has been voluntarily withdrawn from sale for safety or efficacy reasons.
Pending
*11/02/2007 2007P-0438 National Toxic Encephalopathy Foundation/Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified Pending
*11/05/2007 2007P-0437 Matrix Laboratories, Inc. /To permit the filling of abberviated new drug applicacation (ANDA for Lopinavir/ritonavirtablets 100 mg/ 25 mg Pending
*11/05/2007 2007P-0283 Endo Pharmaceuticals/Take actions with respect to NDAs and ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients Pending
*11/06/2007 2007V-0441 Night Vision System - A DRS Technologies Company/GCP-2C (V-2) Variance Application for Night Vision System Pending
*11/09/2007 2007P-0333 Shawn Bryant/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa Pending
*11/09/2007 2007P-0333 James Whalen/Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all Pending
*11/09/2007 2007P-0448 Cobalt Laboratories Inc. and Cobalt Pharmaceuticlas Inc/Petition Regarding Precose (Acarbose) Pending
*11/13/2007 2007N-0382 Apotex, Inc./Ramipril Capsules and 180-day generic drug exclusivity Pending
*11/13/2007 2007V-0451 Mountain Megabytes Inc./Laser Light Show  
*11/13/2007 2007P-0450 Ebewe Parenta Pharmaceuticals, Inc./Determine whether a 200 mg/ vial presentation of Oxaliplatin for Injection (lyophilized powder for infusion) may be file as an Abbreviated New Drug Application Suitability Pending
*11/26/2007 2007P-0457 Mandatory Alternatives Petition Coalition/Mandatory Use of Non-Animal Methods in the Development and Approval of Drugs and Devices Pending
*11/30/2007 2007P-0465 United Research Laboratories, Inc. Mutual Pharmaceutical Company, Inc./Review Labeling and Bioequivalence Standards for Felodipine Extended-Release Tablets to Incorporate Safety Information and Ensure Equivalent Product Safety and Effectiveness Pending
*11/30/2007 2007P-0466 Medicure Pharma/Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate Pending
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December      
*12/04/2007 2007P-0470 Terence J. Mix, Esq./Administrative action regarding CLOMID (clomiphene citrate), NDA 16-131 and its generics Pending
*12/06/2007 2007P-0473 W. L. Driscoll/To seek the creation of a new Food and Drug Administration policy to achieve expanded anh accelerated development and production of pre-pandemic and pandemic vaccine Pending
*12/10/2007 2007P-0475 Alston & Bird LLP/Take the following action with respect to the scheduling and conduct of inspections associated with drugs manufactured or processed at domestic and foreign facilities Pending
*12/12/2007 2007V-0476 X- Laser, L. L. C. / Laser Display Device Pending
*12/12/2007 2007V-0477 X- Laser L. L. C./Laser Light Show Pending
*12/12/2007 2007V-0048 Baylor University/Laser Light Show Pending
*12/12/2007 2007P-0483 Judy Slome Cohain/Restore FDA approval to Tecsana Epi-no birth trainer and to remove the adverse event report on Tecsana Epi-No from FDA website Pending
*12/17/2007 2007P-0479 Consumers Union/Require that all print and electronic advertisements, including Internet advertisements, for implantable devices such as knee, hip, heart valves, cosmetic implants, and other devices Pending
*12/18/2007 2007P-0482 Physicians Committee for Responsible Medicine (PCRM)/Change the labeling for Avandia and other drugs in the thiazolidinedione class to include information that a low-fat vegan diet has an efficacy that is comparable to that of oral medications at managi
Pending
*12/20/2007 2007P-0486 Michael J. Dochniak/Issue a regulation for Hevea Basiliensis natural-rubber-latex, used in the manufacture of infant products Pending
*12/20/2007 2007V-0490 KRP Music Work/Laser Light Show Pending
*12/21/2007 2007P-0488 Mutual Pharmaceutical Company, Inc./Ensure that newly discovered CYP450 system phenotyping (metabolism) and inhibition information is appropriately incorporated into labeling for Felodipine Extended-Release Tablets USP (and other felodi Pending
*12/21/2007 2007N-0353 GRAS/E Coalition/Drug Products Containing Hydrocodone; Enforcement Action Dates Pending
*12/27/2007 2007P-0499 Beckloff Associates, Inc./Determine whether a food-effect study should be required as part of the demonstration of bioequivalence for clozapine orally disintegrating tablets (ODT), 100 mg Pending
*12/28/2007 2007P-0500 John Edward Erb/Revoke the GRAS standing of the food additive Monosodium Glutamate Pending
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