"65FR78494" indicates a notice of some kind was published in the Federal Register
(FR) for a particular date. The FR can be found at http://www.fda.gov/ohrms/dockets/ and then go to the Federal Register section.
Interim Response is not a final decision on the petition.
| 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20mL was withdrawn for safety or effectivess reasons |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 |
| Top |
| 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 |
| Top |
| 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 |
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 reasons |
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 |
| Top |
| 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 |
| Top |
| 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 |
