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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Consultant Services, Inc/Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons | Pending |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| JRRapoza Associates, Inc./To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness | Pending |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 |
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| 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 |
| Top | |||
| 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 |
| Top | |||
| 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 |
| Top | |||
| 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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