Regulatory Information
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2005 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 | |||
| 01/03/2005 | 2005V-0001 | Slick Production / Laser Light Show | Pending |
| 01/05/2005 | 2005P-0006 | Ben Venue Laboratories / ANDA Suitability Petition for Burnetanide Injection, USP 10mg/40 mL | Pending |
| 01/05/2005 | 2005P-0007 | Lachman Consultant service, Inc. / ANDA Suitability for Risperidone Orally Disintegrting Tablets, 0.25 mg | Approved 03/31/2005 |
| 01/07/2005 | 2005P-0008 | Ivax Pharmaceuticals, Inc./ ANDA for simvastatin tablets 5 mg, 10 mg, 20 mg, and 40 mg | Denied 10/24/2005 |
| 01/07/2005 | 2004P-0003 | B Pierson / Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint | Pending |
| 01/07/2005 | 2005A-0014 | B Pierson / Regarding Hip Joint Metal Constrained | Answer 08/02/2005 |
| 01/10/2005 | 2005V-0009 | Patrick Kane / Projector for a Laser Light Show | Approved 02/15/2005 |
| 01/13/2005 | 2005P-0013 | Lupin Pharmaceuticals, Inc. / ANDA Suitability of Cefixime for Oral Suspension, 200 mg/mL | Approved 04/08/2005 |
| 01/13/2005 | 2005A-0015 | GlaxoSmithKline/ Request for Advisory Opinion Concerning "Orange Book" Listing of Patents | Interim Response 07/07/2005 |
| 01/14/2005 | 2005P-0020 | Perricone Juices / Replace Inaccurate and/or misleading working as unpasteurized and replace it with the word untreated | Interim Response 07/13/2005 |
| 01/18/2005 | 2005P-0023 | Apotex corp. / Determine if Tequin Injection 10mg/mL (200 mg)- 20mL was withdrawn for safety or effectivess reasons | Answer 02/10/2006 |
| 01/18/2005 | 2005P-0051 | Ed Groves, Sr. / Approve bottled water labels include either fluoride added or no fluoride added | Pending |
| 01/25/2005 | 2005P-0035 | Phelon Parts, Inc. / Authorizing Phelon Parts, Inc. to purchase and use nitrous oxide gas as part of the manufacturing process of the Phelon Group | Interim Response 07/26/2005 |
| 01/25/2005 | 2005P-0037 | Warner Chilcott Inc. / Regarding Product of Estradiol Vaginal Cream | Interim Response 07/19/2005 |
| 01/26/2005 | 2005P-0034 | Public Citizen Health Research Group / Remove the COX-2 Inhibitors Celecoxib (celebrex) and Valdecoxib (Bextra) from the Market | Approved 07/26/2005 Petition is granted in part and denied in part |
| 01/27/2005 | 2005A-0039 | McKenna, Long & Aldridge / To issue an advisory opinion with respec tto agency limitations during inspection of or inquiries to devices manufacturers whose facilities are located outside the jurisdiction of the US | Pending |
| 01/28/2005 | 2005P-0044 | Lachman Consultant Services, Inc./ ANDA Suitability for Chlorozoxazone Tabletsw USP, 375 mg | Approved 04/08/2005 |
| 01/31/2005 | 2005V-0041 | Showlasers, Inc. / Projector for a Laser Light Show | Closed moved to 1980P-0495 |
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| February | |||
| 02/01/2005 | 2005P-0046 | Ranbaxy Laboratories Limited / Removal of Patent Listings by Reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed | Denied 10/24/2005 |
| 02/01/2005 | 2005P-0048 | McNeil Consumer & Specialty Pharmaceuticals/ Professional labeling for aspiring dosing in order to specify the more favorable benefit/risk profile of aspirin doses of 75-150mg/day for secondary cardiovascular prevention | Interim Response 07/28/2005 |
| 02/02/2005 | 2005P-0050 | Pharmaceutical Resources Group Consulting / ANDA Suitability for colistimethate Sodium 150 mg/2 mL Solution | Approved 10/18/2005 |
| 02/03/20905 | 2005V-0052 | Black Oak Casino / Projector for a Laser Light Show | Approved 05/19/2005; Termination date: 05/19/2007 |
| 02/03/2005 | 2005V-0053 | Harvey Freelon / Projector for a Laser Light Show | Approved 05/19/2005; Termination date: 05/19/2007 |
| 02/04/2005 | 2005V-0054 | Gilmore Entertainment Group, LLC / Laser Light Show | Pending |
| 02/07/2005 | 2004P-0003 | B Pierson / Petition to reconsider the Food and Drug Administration's decision on the Med watch complaint | Pending |
| 02/07/2005 | 2005A-0014 | B Pierson / Regarding hip joint metal constrained | Answer 08/02/2005 |
| 02/09/2005 | 2005P-0061 | Sun Pharmaceutical Industries LTD. / Determine whether the listed drug has been withdrawn for safety or effectivess reasons | Approved 03/25/2005 |
| 02/09/2005 | 2005P-0121 | RS Medical / None-Invasive Bone Growth Stimulator be Reclassified from Class III To Class II | Withdrawn 04/02/2007 |
| 02/10/2005 | 2005P-0060 | Lachman Consultant Services, Inc. / ANDA Suitability of Hydrochlorothiazide Tablets 12.5 mg | Approved 04/08/2005 |
| 02/11/2005 | 2005V-0064 | Laser Image Productions, Inc. Projector for a Laser Light Show | Closed 03/22/2005 Moved to Docket Number 1988V-0165 |
| 02/11/2005 | 1988V-0165 | Laser Image Productions, Inc. Variance re: Laser Light Show Projector (LIP-88-1) | Pending |
| 02/14/2005 | 2005P-0066 | DLA Piper Rudnick Gray Cary / ANDA Suitability for Amiodipine Besylate Capsules 2.5, 5, and 10 mg | Denied 06/07/2006 |
| 02/15/2005 | 2005P-0070 | Bone Medical Limited / ANDA Suitability for Oral Salmon Calcitonin | Denied 06/02/2006 |
| 02/15/2005 | 2005P-0072 | New York Medical College, et al / Withholding of safety information regarding risks of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Associated with ibuprofen products | Approved 06/22/2006 |
| 02/16/2005 | 2005V-0073 | William McHugh / Laser Light Show | Approved 03/31/2005 |
| 02/16/2005 | 2005P-0074 | Aplicare, Inc. / Chlorhexidine Bluconate 2%w/v and Isopropyl Acohol 70% v/v patient preoperative skin preparation 3mL, in different dosage form suitable for ANDA | Pending |
| 02/17/2005 | 2005P-0076 | Kirk Van Rooyan and Barbara Van Rooyan/OxyContin and Paladone removal from market and label changes limited indications to severe chronic pain | Interim Response 08/15/2005 |
| 02/18/2005 | 2005V-0078 | Woodcrest Lanes / laser Display Device | Pending |
| 02/22/2005 | 2005P-0079 | Teva Pharmaceuticals USA / Determine whether Vioxx Tablets, manufacturered by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons | Interim Response 08/22/2005 |
| 02/22/2005 | 2005P-0080 | Lachman Consultant Services, Inc. / ANDA Suitability for Prednisolone Sodium Phosphate Solution 10mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base) | Pending |
| 02/23/2005 | 2005P-0084 | World Wide Medical Technologies / Commercial Brachytherapy Kits for Treatment of Prostate Cancer; Non-Absorbable Bone Wax; Non-Absorbable Reformulated "Faux Bone Wax" Needle Pluts | Pending |
| 02/23/2005 | 2005P-0085 | McGuff Pharmaceuticals Inc. / Provide a generic form of Endrate Disodium Injection, USP in secondary package configurations of a single box containing one vial and/or trays containing twenty-five vials per tray | Withdrawn 05/09/2005 |
| 02/25/2005 | 2005V-0086 | Maple Park Media /Laser Light Show | Approved 03/31/2005 |
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| March | |||
| 03/01/2005 | 2005P-0090 | Arthur K. Yellin / Amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis, intended purpose and actual societal needs | Pending |
| 03/04/2005 | 2005P-0093 | Arthur K. Yellin /Revoke part of 5 CFR 5501.104(b)(3) prohibits ownership of financial interest in a publicly traded or publicly available investment fund | Pending |
| 03/04/2005 | 2005P-0094 | Public Citizen's Health Research Group / Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately | Interim Response 08/31/2005 |
| 03/04/2005 | 2005P-0095 | Luitpold Pharmaceuticals, Inc. / ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer (Iron sucrose) injection USP | Interim Response 08/31/2005 |
| 03/07/2005 | 2005P-0096 | Silarx Pharmaceuticals, Inc. / ANDA 77-421 Loratadine Syrup-Hives Relief | Answer 02/03/2006 |
| 03/15/2005 | 2005P-0104 | Arnall Golden Gregory LLP/ Determine whehter Peptavion (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness | Answer 02/10/2006 |
| 03/17/2005 | 2005P-0107 | University of California, San Francisco/ Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women | Interim Response 09/08/2005 |
| 03/18/2005 | 2005V-0108 | Lorenzo Entertainment, Inc. / Laser Light Show | Approved 10/14/2005 |
| 03/23/2005 | 2005P-0114 | Samson Medical Technologies, LLC/ ANDA for Ceftriaxone for injection, USP, pharmacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foi outler wraps | Approved 07/12/2005 |
| 03/24/2005 | 2005P-0115 | Public Citizen / Immediately remove from the market pemoline CYLER-Abbott Laboratories, and all generic versions | Denied 05/01/2006 |
| 03/24/2005 | 2005P-0116 | Consumer Health Alliance for Safe Medication / To take actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations | Interim Response 09/20/2005 |
| 03/25/2005 | 2004P-0239 | GlaxoSmithKline / Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products | Denied 02/22/2006 |
| 03/25/2005 | 2004P-0523 | GlaxoSmithKline / Generic Fluticasone Propionate Nasal Spray Products should meet the Same High Standards of Quality as GSK's barnd-name product Flonase | Denied 02/22/2006 |
| 03/31/2005 | 2005V-0126 | Endo & Son / Projection for a Laser Light Show | Approved 05/19/2005; Termination 05/19/2007 |
| 03/31/2005 | 2005P-0127 | Aventis Pharmaceuticals, Inc. / Abbreviated New Drug Applications (ANDA's) referencing Arava (leflunomide) Tablets | Denied 09/13/2005 |
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| April | |||
| 04/05/2005 | 2005A-0131 | Great Lakes Orthodontics, Ltd. / Request for an Advisory Opinion concerning a 510(k) for a Medical or Dental Device | Withdrawn 11/08/2005 |
| 04/06/2005 | 2005P-0134 | ISTA Pharmaceuticals / Concerning Marketing Exclusivity for Vitrase (NDA 21-64) | Denied 10/25/2005 |
| 04/07/2005 | 1999V-0294 | Lost Tribe / Laser Light Show | Pending |
| 04/08/2005 | 2005P-0139 | Environmental Defense / Withdrawal of Approvals of certain Herdwide/Flockwide uses of Critically and Highly Important Antibiotics pursuant to Guidance #152 | Interim Response 10/04/2005 |
| 04/08/2005 | 2005P-0140 | Lachman Consultant Services, Inc. / ANDA Suitability for Oxycodone Hydrochloride, 7.5 mg Tablets, USP | Approved 07/14/2005 |
| 04/08/2005 | 2005V-0141 | Scott Laser Technologies / Laser Light Show | Approved 05/19/2005; Termination date 05/19/2007 |
| 04/08/2005 | 2005V-0142 | Off the Record Mobile Dance Club & Video / Laser Light Show | Pending |
| 04/11/2005 | 2005V-0145 | Disneyland Resourt / Laser Light Show | Approved 05/09/2005 |
| 04/13/2005 | 2005P-0144 | The Weinberg Group Inc / ANDA Suitability for Oxycodone Hydrochloride 20 mg/mL Oral Solution | Denied 03/28/2006 |
| 04/14/2005 | 2005P-0146 | Salix Pharmaceuticals Inc / Establish Guidance or Regulations Providing Bioequivalence Requirement for Oral Locally-Acting Gastrointestingal Drug Products Prior to Approval of any Generic Versions of Such Drugs | Interim Response 10/11/2005 |
| 04/15/2005 | 2005V-0152 | Insight Technology Incorporated / Laser Light Show | Pending |
| 04/19/2005 | 2005V-0154 | Spectronika LTD / Laser Display Device | Approved 12/21/2005 |
| 04/21/2005 | 2005P-0156 | Phase V Pharmaceuticals / Permission to File an Abbreviated New Drug Application for Baclofen Oral Solution | Withdrawn 07/05/2005 |
| 04/26/2005 | 2005P-0161 | Lachman Consultant Services Inc / ANDA Suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Tablets | Pending |
| 04/26/2005 | 2005P-0162 | Lachman Consultant Services Inc / ANDA Suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5mL | Pending |
| 04/27/2005 | 2005V-0163 | Peachstate Audio & Lighting / Projector for a Laser Light Show | Approved 05/19/2005; Termination date 05/19/2007 |
| 04/27/2005 | 2005V-0164 | Patrick AFB Rocket Lanes / Laser Light Show | Approved 12/18/2006 |
| 04/29/2005 | 2005V-0165 | EMC Inc. dba The Boiler Room / Projector for a Laser Light Show | Approved 05/06/2005 |
| 04/29/2005 | 2005N-0077 | International Association of Color Manufacturers / Color Additive Certification; Increase in Fees for Certification Services | Pending |
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| May | |||
| 05/02/2005 | 2005N-0077 | International Association of Color Manufacturers / Color Additive Certification; Increase in Fees for Certification Services | Pending |
| 05/02/2005 | 2003P-0159 | Wyeth Pharmaceuticals / Venlafaxine Hydrochloride Extended-Release Tablets | Pending |
| 05/02/2005 | 2005P-0166 | International Myopia Prevention Association / Prevent the Unlawful Misbranding of Prescription Distance Glasses and Contact Lenses | Denied 08/02/2006 |
| 05/03/2005 | 2005V-0171 | Moody Planetarium The Museum Texas Tech University / Laser Light Show | Approved 06/08/2005; Termination date 06/08/2008 |
| 05/04/2005 | 2005P-0167 | State of Connecticut / Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events | Approved 05/25/2006 in Part and Denied in Part |
| 05/04/2005 | 2005P-0168 | ACADERM Inc. / Determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol, 0.01% (NDA 083-296) has not been voluntarily withdrawn for safety or efficacy reasons | Interim Response 10/31/2005 |
| 05/05/2005 | 2005V-0172 | Connecticut Lasertainment / Laser Light Show | Approved 07/12/2005 |
| 05/05/2005 | 2005P-0173 | Buchanan Ingersoll / Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP | Approved 04/26/2006 petition is granted in part and denied in part |
| 05/06/2005 | 2005P-0170 | Intervet Inc. / ANADA for a generic ivermectin soft chew that differes in dosage form for horses | Approved 07/01/2005 |
| 05/09/2005 | 2005P-0176 | Lachman Consultnat Services, Inc. / Make a determination that Cefditoren Pivoxil Tablets, 400 mg is suitable for submission as an ANDA | Approved 07/14/2005 |
| 05/10/2005 | 2005V-0177 | Club Miami / Projector for a Laser Light Show | Pending |
| 05/10/2005 | 2005V-0181 | Deflexion LLC / Laser Light Show | Pending |
| 05/10/2005 | 2005P-0179 | Kilpatrick Stockton LLP / ANDA suitability for ribavirin, USP tablets in strength of 500 mg | Approved 07/14/2005 |
| 05/11/2005 | 2005P-0180 | Lachman Consultant services, Inc. / ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets in the following strength, 2.5 mg / 200 mg | Approved 07/14/2005 |
| 05/12/2005 | 2005P-0182 | Antibody Systems Inc. / Withdraw April 14, 2003, Warning Letter, CBER 03-010 addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA | Interim Response 10/31/2005 |
| 05/13/2005 | 2005P-0187 | Edward John Kronenberger III / Amend 21 CFR 177.2280 pertaining to Liquid Epoxy tresin to remove phenyl glycidyl ether as a permissible constitutent | Pending |
| 05/16/2005 | 2005V-0188 | Best Entertainment / Laser Light Show | Approved 04/17/2006 |
| 05/16/2005 | 2005V-0194 | Ogden Dinosaur Park and Museum / Laser Light Show | Approved 06/08/2005; Termination date 06/08/2007 |
| 05/18/2005 | 2005P-0196 | Sun Pharmaceutical Industries Ltd. / Discontinued Formulation of Pantoprazole Sodium Injection | Interim Response 11/14/2005 |
| 05/18/2005 | 2005V-0197 | Southwest SMU Planetarium / Laser Light Show | Pending |
| 05/18/2005 | 2005V-0198 | Sapphire Night Club / Projector for a Laser Light Show | Approved 03/28/2006 |
| 05/23/2005 | 2005P-0189 | Martek Biosciences Corporaiton / Nutrient Content Claims for ALA and DHA omega-3 fatty acids | Interim Response 11/27/2007 |
| 05/23/2005 | 2005P-0207 | Life Measurement, Inc. / Change in Classification for Sonomet Body Composition Analyzer, BOD POD and PEAPOD | Interim Response 10/26/2005 |
| 05/24/2005 | 2005P-0204 | Zuckerman Spaeder LLP / Deny the pre-market approval application of Mentor corporation and Inamed Corporation for approval of silicone-gel filled breast implant products | Denied 11/17/2006 |
| 05/24/2005 | 2005P-0205 | Office of Illinois Attorney General / Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture | Interim Response 11/16/2005 |
| 05/24/2005 | 2005V-0206 | Glock, Inc. / Laser Light Show |
Approved 06/16/2005
|
| 05/27/2005 | 2005P-0212 | Pharmaceutical Patent Attorneys / ANDA suitability petition for Lamotrigine 50 milligram and 250 milligram oral tablets | Withdrawn 06/09/2005 |
| 05/27/2005 | 2005P-0293 | D. J. Getoff/Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies | Interim Response 12/08/2005 |
| 05/31/2005 | 2005P-0213 | Scientific Laboratory Products LTD / To change the classification of EEG electrodes currently classified as class II and requiring 510(k) approval | Withdrawn 04/19/2006 |
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| June | |||
| 06/07/2005 | 2005V-0222 | Roper Mountain Science Center / Laser Light Show | Approved 05/04/2006 |
| 06/07/2005 | 2005P-0221 | Allentown Health Bureau / Amend the regulations governing the labeling of milk products in 21 CFR 131 | Interim Response 11/21/2005 |
| 06/09/2005 | 2005P-0224 | Physicians Committee Responsible Medicine / To request administrative action regarding the purported weight and fat loss benefits of dairy products | Withdrawn 07/29/2005 |
| 06/10/2005 | 2005P-0225 | The Weinberg Group Inc. / Oxycodone Hydrochloride Controlled Release Tablets in strengths of 30 mg and 60 mg for ANDA | Approved 07/15/2005 |
| 06/10/2005 | 2005P-0226 | Aplicare, Inc. / Declare that Chlorhexidine Gluconate 2% w/v and isopropyl alcohol 70% v/v Patient Preoperative Skin Preparation 3 mL, is suibable for consideration as an ANDA | Pending |
| 06/13/2005 | 2005P-0228 | Lachman Consultant Services, Inc. / ANDA Suitability for Ranitidine Hydrochloride Suspension (15 mg base/mL) | Withdrawn 05/24/2006 |
| 06/13/2005 | 2005V-0229 | Anaphase Design / Mobile Laser Show | Pending |
| 06/13/2005 | 2005V-0230 | Crazy Horse Memorial / Laser Light Show | Approved 08/03/2005 |
| 06/15/2005 | 2005P-0232 | Elizabeth M. Trevino / Baby Chamomile Juice, 100% natural juice | Pending |
| 06/15/2005 | 2005P-0237 | Pharmaceutical Patent Attorneys, LLC / Re-Listing Petitoin to determine that two strengths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns | Interim Response 12/13/2005 |
| 06/17/2005 | 2005P-0243 | The International Institute for Clinical Research-New York / Permit the filing for 2% Lidocaine hydrochloride for topical (spray) anesthesia with a flavor as an ingredient | Pending |
| 06/20/2005 | 2005P-0244 | ECR Pharmaceuticals / Decadron (dexamethasone USP) 1.5 mg tablet strength was not removed from the market for safety or efficacy reasons | Pending |
| 06/21/2005 | 2005P-0242 | Samson Medical Tehnologies, LLC / ANDA for a sterile vancomycin Hydrochloride, USP bulk package in 100 gram dosage strength in plastic bags | Approved 04/19/2006 |
| 06/22/2005 | 2005P-0257 | The Weinberg Group Inc. / Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, suitable for submission as an ANDA | Approved 11/14/2005 |
| 06/24/2005 | 2005V-0260 | Fisher Theatrical / Laser Light Show | Approved 08/03/2005 |
| 06/27/2005 | 2005P-0265 | J Salsman / Over-the-Counter Sale of Modafinil | Interim Response 12/22/2005 |
| 06/27/2005 | 2005P-0266 | Stone Mountain Media LLC / Laser Light Show | Pending |
| 06/28/2005 | 2005P-0267 | American College of Gastroenterology / Remove from labeling for propofol (Diprivan) the warning that propofol should be administered only be trained persons | Interim Response 12/21/2005 |
| 06/28/2005 | 2005V-0268 | Alchemy Concern Systems, LLC / Projector for a Laser Light Show | Approved 08/01/2005 Termination date 08/01/2007 |
| 06/28/2005 | 2005P-0269 | Claxton bakery et al/ Amend 21CFR 101.12(b) Table 2 Reference Amount Customarily Consumed Per eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces) | Denied 12/21/2005 |
| 06/29/2005 | 2005P-0275 | Taro Parmaceuticals USA Inc / Request for a change to a listed drug to allow submission of an Abbreviated new Drug Application for Lidocaine Hydrochloride Injection USP, 2% | Withdrawn 06/29/2005 |
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| July | |||
| 07/06/2005 | 2005P-0273 | Rutgers University / Add Calcium to the Mandatory List | Interim Response 01/18/2006 |
| 07/08/2005 | 2005P-0277 | Pfizer Animal Health / ANADA Suitability for generic version of EXCENEL RTU, ceftiofur hydrochloride sterile suspendion | Withdrawn 07/22/2005 |
| 07/08/2005 | 2005P-0278 | National Institute of Oilseed Products / Prior notice of imports (21 CFR part 1, subpart 1) and establishment and maintenance of records (21CFR Part 1, subpart J) | Pending |
| 07/11/2005 | 2005V-0280 | Sidram Services Inc / Projector for a Laser Light Show | Pending |
| 07/13/2005 | 2005P-0282 | Center for Science in the Public Interest (CSPI) / Require Health Messages on Soft Drinks | Pending |
| 07/14/2005 | 2005V-0281 | C/J Media dba InterVision / Laser Light Show | Approved 07/22/2005 |
| 07/19/2005 | 2005V-0287 | Kiss Nightclub/Projector for a Laser Light Show | Approved 08/03/2005 |
| 07/22/2005 | 2005P-0292 | Medtronic Xomed/513(e) Reclassification Petition for Lamicel Osmotic Cervical Dilator | Withdrawn 10/12/2005 |
| 07/26/2005 | 2005P-0291 | Frommer Lawrence and Haug LLP/ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride | Interim Response 01/24/2006 |
| 07/26/2005 | 2005V-0294 | Demilune Digital Designs/Laser Light Show | Approved 09/08/2005 |
| 07/26/2005 | 2005P-0295 | Alaska Birch Syrupmakers Association/Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup | Interim Response 12/14/2005 |
| 07/29/2005 | 2005P-0300 | Amide Pharmaceutical, Inc./Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness | Interim Response 01/25/2006; Answer 07/14/2006 |
| 07/29/2005 | 2005V-0301 | Club Element/Laser Light Show | Approved 05/24/2006 |
| 07/29/2005 | 2005P-0305 | BioStratum, Inc. (BioStratum)/Remove Dietary Supplements that Contain the Drug Pyridoxamine | Pending |
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| August | |||
| 08/02/2005 | 200V-0306 | Profound Sound/Laser Light Show | Pending |
| 08/03/2005 | 2005P-0307 | Morton Grove Pharmaceuticals, Inc./ANDA Suitability for Warfarin Sodium Solution | Pending |
| 08/05/2005 | 2005V-0309 | Topeka Fun Inc, /DBA Lollipops Gentlemens Club/Laser Light Show | Approved 08/29/2005 |
| 08/09/2005 | 2005V-0313 | Oxygen Sound LLC,/Laser Light Show | Approved 06/01/2006 |
| 08/09/2005 | 2005V-0314 | Anthony Fransen Productions/Laser Light Show | Approved 10/05/2005 |
| 08/09/2005 | 2005P-0315 | CanReg, Inc./ANDA for Ursodiol Oral Suspension, 20 mg/mL | Pending |
| 08/09/2005 | 2005V-0316 | Beau Rivage Resort/Laser Light Show | Pending |
| 08/11/2005 | 2005P-0319 | Sonnenchein, Nath & Rosenthal, LLP/Determination of PHENERGAN (Promethazine hydrochloride) | Interim Response 02/09/2006; Answer 07/14/2006 |
| 08/11/2005 | 2005P-0322 | Insmed Incorporated/Immediately deny approval of the NDA for INCRELEX | Denied 08/30/2005 |
| 08/12/2005 | 2005P-0323 | David S. Lowe/Immediately remove Adderall and Adderall XR from the market for safety reasonsWithdrawn 06/21/2006 | Withdrawn 06/21/2006 |
| 08/16/2005 | 2005P-0325 | The Sugar Association/Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners |
Interim Response 02/13/2006 |
| 08/16/2005 | 2005V-0326 | Optical Magic/Projector for a Laser Light Show | Closed 09/27/2005 Moved to 2002V-0453 |
| 08/18/2005 | 2005P-0332 | American Bakers Association/amnd the food definitions and standards of identity for bakery products (21 C.F.R. Part 136) and to repeal the Food definition and standard identitiy and quality for frozen cherry pie |
Interim Response 02/09/2006 |
| 08/19/2005 | 2005V-0333 | Prilor LLC / Amika Nightclub/Projector for a Laser Light Show | Approved 09/07/2005 |
| 08/19/2005 | 2005V-0336 | Stargate Mfg. LLC/Laser Light Show | Approved 09/09/2005 |
| 08/26/2005 | 2000N-1571 | Bayer Corporation/Enrofloxacin for Poultry: Opportunity for Hearing | Denied 09/02/2005 |
| 08/26/2005 | 2000N-1571 | Animal Health Institute/Enrofloxacin for Poultry: Opportunity for Hearing | Denied 09/02/2005 |
| 08/26/2005 | 2000N-1571 | American College of Poultry Veterinarians et al/Enrofloxacin for Poultry: Opportunity for Hearing | Denied 09/02/2005 |
| 08/29/2005 | 2005P-0351 | Morton Grove Pharmaceuticals, Inc./Losartan Potassium Oal Solution make a determination that it may be submitted for ANDA |
Pending |
| 08/30/2005 | 2005P-0352 | Ortho-McNeil Pharmaceutical, Inc./bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin |
Approved 11/09/2006 |
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| September | |||
| 09/01/2005 | 2005P-0358 | Council Radionuclides Radiopharmaceuticals/Determine that sponsors of human drug applications for positron emission tomography (PET) drug be exempt from paying certain user fees assessed pursuant to the prescription drug. |
Interim Response 03/01/2006; Withdrawn 10/02/2007 |
| 09/06/2005 | 2005P-0360 | Foley & Lardner LLP/salmon calcitonin products unless certain conditions are met FDA should not approved |
Interim Response 03/06/2006 |
| 09/01/2005 | 2005V-0365 | Hologic, Inc./Laser Light Show | Pending |
| 09/08/2005 | 2005V-0361 | Philips Medical Systems/Variance request for a performance standand for a radiographic systems | Pending |
| 09/12/2005 | 2005V-0368 | Prismatic Magic LLC/Projector for a Laser Light Show for Flare F1-1104; Flint: F2-0104; Firefly : F3- 0905 |
Approved 06/26/2006 |
| 09/12/2005 | 2005V-0369 | Prismatic Magic LLC/Projector for a Laser Light Show Gozer: G3-0405; Gryphon: G4-090 | Closed 07/05/2006 Moved to 2005V-0368 |
| 09/12/2005 | 2005V-0370 | Prismatic Magic LLC/Projector for a Laser Light Show Gizmo: G1-0504; Grendel: G2-0904 | Closed 07/05/2006 Moved to 2005V-0368 VAR 3 |
| 09/12/2005 | 2005V-0371 | Prismatic Magic LLC/Projector for a Laser Light Show Goliath: G0-0704 | Closed 07/05/2006 Moved to 2005V-0368 VAR 4 |
| 09/12/2005 | 2005V-0372 | Prismatic Magic LLC/Projector for a Laser Light Show Phoenix: F4-1005 | Closed 07/05/2006 Moved to 2005V-0368 VAR 5 |
| 09/13/2005 | 1987V-0272 | HFZ-200 to Charles Hayden Planetarium/Laser light show |
Pending |
| 09/14/2005 | 2005P-0377 | Department of the Planet Earth/Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives | Pending |
| 09/14/2005 | 2004Q-0083 | Fleminger Inc/Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer | Pending |
| 09/20/2005 | 2005P-0384 | Eric K. Pritchard/Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine | Interim Response 05/01/2006 |
| 09/20/2005 | 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. | Denied 12/01/2006 |
| 09/19/2005 | 2005P-0405 | Orthopedic Surgical Manufacturers Association (OSMA)/Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components |
Pending |
| 09/27/2005 | 2005P-0398 | Lachman Consultant Services, Inc./ANDA Suitability for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose vial |
Pending |
| 09/27/2005 | 2005P-0400 | Donna Ricks/permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer |
Closed 03/27/2006 |
| 09/28/2005 | 2005P-0402 | Ross J. Baldessarini, M.D. & Frederick K. Goodwin, M.D./Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness." |
Interim Response 03/22/2006 |
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| October | |||
| 10/03/2005 | 2005P-0406 | Lachman Consultant Services, Inc./Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA |
Approved 06/27/2007 |
| 10/04/2005 | 2005P-0407 | Lachman Consultant Services, Inc./ANDA for Efavirenz Tablets for Oral Suspension 50 mg, 100 mg and 200 mg |
Pending |
| 10/05/2005 | 2005P-0409 | Sterne, Kessler, Goldstein & Fox, P.L.L.C./Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray |
Denied 10/20/2006 |
| 10/06/2005 | 2005P-0408 | Dan M. Kelch/Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor |
Interim Response 04/14/2006 |
| 10/06/2005 | 2005P-0411 | Wyeth/Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs |
Interim Response 03/31/2006 |
| 10/13/2005 | 2005V-0415 | OrthoScan HD/performance standard for fluoroscopic equipment mfged by OrthoScan | Pending |
| 10/18/2005 | 2005P-0417 | Triax Pharmaceuticals, LLC/ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075% | Approved 05/09/2007 |
| 10/18/2005 | 2005P-0418 | Lachman Consultant Services, Inc./Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA |
Withdrawn 11/16/2005 |
| 10/18/2005 | 2005P-0420 | Shire Pharmaceuticals Group/Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP |
Interim Response 04/17/2006 |
| 10/19/2005 | 2005P-0421 | Duane Morris/To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information |
Interim Response 04/17/2006 |
| 10/20/2005 | 2005P-0423 | Public Citzen's Health Research Group/Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion | Interim Response 04/18/2006 |
| 10/24/2005 | 2005P-0429 | Cinergen/re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended | Interim Response 04/19/2006 |
| 10/25/2005 | 2005P-0430 | Gregory E. Skipper. M. D./Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act. |
Interim Response 04/19/2006 |
| 10/25/2005 | 2005P-0431 | CooperSurgical, Inc./Reclassification of P990016 McCue CUBA Clinical Ultrasonic Bone Sonometry System |
Interim Response 04/19/2006 |
| 10/25/2005 | 2005P-0432 | Beyond Pesticides, et al/Ban all Non-medical Uses of the Antibacterial Agent Triclosan | Interim Response 04/19/2006 |
| 10/25/2005 | 2005P-0433 | Natural Solutions Foundation/Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512 |
Pending |
| 10/28/2005 | 2005P-0436 | Banner Pharmacaps Inc. of High Point/ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd. | Interim Response 04/25/2006 |
| 10/25/2005 | 2005P-0397 | Tm Bioscience Corporation/Classification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System |
Pending |
| 10/28/2005 | 2005P-0441 | Gordon L. Flynn, Ph.D./Reservoir Systems for Transdermal Delivery | Interim Response 04/24/2006 |
| 10/31/2005 | 2005V-0439 | The Factory at Walnut LLC/Laser Light Show | Pending |
| 10/31/2005 | 2005P-0440 | Wright Medical Technology, Inc./To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA | Denied 05/09/2006 |
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| November | |||
| 11/02/2005 | 2005P-0442 | Pine Grove Behavioral Health & Addiction Services/For patient safety and public health considerations,recommending scheduling tramadol under the Controlled Substances Act | Interim Response 04/26/2006 |
| 11/07/2005 | 2005P-0449 | The Quaker Oats Company/Amend existing regulations authorizing health claims relating beta-glucan soluble fiber from specific whole oat sources to reduced risk of coronary heart disease, to permit foods which exceed the nutr |
Answer 12/22/2005 |
| 11/08/2005 | 2005P-0450 | Center for Science in the Public Interest/Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium |
Interim Response 06/05/2006 |
| 11/08/2005 | 2005P-0456 | Sandoz Inc./Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons |
Interim Response 05/04/2006 |
| 11/10/2005 | 2005P-0452 | Pfizer/FDA's decisions concerning approvals of generic versions of atorvastatin | Interim Response 05/04/2006 |
| 11/10/2005 | 2005P-0453 | Public Citizen's Health Research Group/FDA to establish tighter regulations governing the process by which medical devices are reviewed and recalled | Pending |
| 11/11/2005 | 2005P-0460 | Lachman Consultant Services, Inc./Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg |
Withdrawn 05/01/2007 |
| 11/14/2005 | 2005P-0458 | Medi-Flex, Inc./Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired | Withdrawn 01/22/2007 |
| 11/15/2005 | 2005P-0459 | Kalsec Inc./To enforce ban on carbon monoxide gas in fresh meat packaging | Pending |
| 11/15/2005 | 2005P-0462 | Consumers for Dental Choice/Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam | Approved 10/26/2006 |
| 11/15/2005 | 2005P-0464 | GlaxoKline/Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone- depleting substance |
Interim Response 05/15/2006 |
| 11/15/2005 | 2005V-0461 | New Orleans City Park Inprovement Association/Laser Light Show | Pending |
| 11/16/2005 | 2005P-0463 | Rosei Rocha-Judd/requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act | Interim Response 05/10/2006 |
| 11/16/2005 | 2005P-0465 | Consumers for Dental Choice/Withdraw Draft Regulation on Mercury Amalgam | Approved 10/26/2006 |
| 11/16/2005 | 2005P-0472 | Pharmaceutical Patent Attorneys, LLC/ANDA for Ramipril Instant Release Oral Tablets | Pending |
| 11/23/2005 | 2005P-0480 | Camargo Pharmaceutical Services/Meloxicam, Orally Disintegrating Tablets, 7.5 mg and 15 mg is suitable for submission as an ANDA |
Pending |
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| December | |||
| 12/06/2005 | 2005P-0487 | U.S. Public Interest Research Group/Require manufacturers to stop using xylene, toluene, and dibutyl phthalate in nail polish marketed for children under the age of 14. | Denied 03/06/2007 |
| 12/08/2005 | 1976N-0052G | American Council on Regulatory Compliance/OTC general comments & combinations | Pending |
| 12/13/2005 | 2005V-0489 | Fullhouse Productions L.L.C./Laser Light Show | Pending |
| 12/15/2005 | 2005P-0493 | Breckenridge Pharmaceutical, Inc./Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products | Interim Response 06/07/2006 |
| 12/15/2005 | 2005P-0213 | Scientific Laboratory Products/To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\ |
Pending |
| 12/20/2005 | 2005P-0496 | Mayne Pharma (USA) Inc./ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL | Pending |
| 12/20/2005 | 2005P-0495 | Vigconic (International), Ltd./Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005 | Approved 01/16/2007 |
| 12/20/2005 | 2005P-0498 | Keller and Heckman LLP/Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) | Approved 12/14/2006 |
| 12/20/2005 | 2005P-0501 | Hyman, Phelps & McNamara, P.C/To revise the FDA's guidance document entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disea | Interim Response 06/16/2006 |
| 12/21/2005 | 2005V-0499 | NVEC (Night Vision Equipment Company)/Laser Light Show regarding GCP-1,GCP-2 | Approved 04/17/2006 |
| 12/21/2005 | 2005P-0502 | Number not used | Pending |
| 12/23/2005 | 2005P-0458 | Medi-Flex, Inc./Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired | Withdrawn 01/22/2007 |
| 12/27/2005 | 2005P-0509 | W. Rucker/Evaluation that Psychosis Is a Adverse effect of Keppra (levetiracetam) | Interim Reponse 06/22/2006 |
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