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U.S. Department of Health and Human Services

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 / Determine if Tequin Injection 10mg/mL (200 mg)- 20mL was withdrawn for safety or effectivess reasons Answer 02/10/2006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
Top      
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
Top      
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
Top      
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
Top      
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
Top      
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
Top      
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
Top      
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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