"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 |
| 01/04/2006 |
2006P-0001 |
Sepracor Inc./Date of Approval for Lunesta (Eszopiclone) Tablets |
Interim Response 06/29/2006 |
| 01/06/2006 |
2006P-0002 |
Lachman Consultant Services, Inc./Methocarbamol Tablets USP,
1000 mg for Abbreviated new drug application (ANDA) |
Pending |
| 01/06/2006 |
2006P-0007 |
Lachman Consultant Services, Inc./Oxycocone Hydrochloride
and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
|
Approved 01/16/2007 |
| 01/06/2006 |
2006V-0013 |
Stace Smith Pro Rodeos/Projector for a Laser Light Show |
Pending |
| 01/12/2006 |
2006P-0030 |
Number not used |
Pending |
| 01/13/2006 |
2006V-0027 |
NVEC (Night Vision Equipment Company)/Laser Light Show regarding
GCO-1A and GCP-2 |
Pending |
| 01/19/2006 |
2006P-0039 |
Food and Drug Law Class/FDA issue new labeling requirements
for caffeinated food products |
Pending |
| 01/20/2006 |
2006A-0041 |
Litron Laboratories/genetic toxicology testing: the Ames Assay,
Mouse Lymphoma Assay and the Micronucleus Assay
|
Pending |
| 01/23/2006 |
2006P-0047 |
SPEC Pharma/Refrain from Approval any ANDA for Celestone Soluspan |
Approved 06/22/2006 |
| 01/23/2006 |
2006V-0048 |
TIA Products/Laser Light Show |
Pending |
| 01/24/2006 |
2006P-0049 |
Synthetic Organic Chemical Manufacturers Association's/reduce
the public health risks associated with the use of drugs manufactured
or processed at foreign facilities
|
Interim Response 07/17/2006 |
| 01/25/2006 |
2006P-0052 |
Lachman Consultant Services, Inc./Determine whether Sustiva
(efavirenz) Tablets, 300 mg (NDA 21- 360), has been voluntarily
withdrawn for safety or effectiveness reasons
|
Interim Response 07/27/2006; Answer 02/02/2007 N1 72FR5061
2/2/07 |
| 01/25/2006 |
2006P-0054 |
Alcohol Monitoring Systems/513(f) Petition for the SCRAM Bracelet
(and Collectively, the SCRAM System) as a Class I Medical Device
|
Pending |
| 01/26/2006 |
2006V-0053 |
Fascanition Laser Systems/Laser Light Show |
Pending |
| 01/27/2006 |
1988N-0258 |
Pharmaceutical Distributors Association/Prescription Drug
Marketing Act of 1987; Guideline |
Denied 08/08/2006 |
| 01/27/2006 |
1992N-0297 |
Pharmaceutical Distributors Assciation/Prescription Drug Marketing
Act of 1987, Drug Amds of 1992 |
Denied 08/08/2006 |
| 01/27/2006 |
2006V-0055 |
William E. Komassa/Variance for a laser Light Show |
Pending |
| Top |
| February |
| 02/01/2006 |
2006P-0060 |
MacLeon Pharmaceuticals Inc./ANADA for Unibute Granules 200
mg phenylbutazone per g of of granules instant of paste
|
Approved 04/04/2006 |
| 02/08/2006 |
2006P-0068 |
Covington & Burling/Determine whether Syntocinon (oxytocin)
Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety
or effectiveness reasons
|
Withdrawn 06/28/2006 |
| 02/09/2006 |
2006P-0070 |
Pfizer Inc./Misbranding of generic azithromycin products marketed
by Teva Pharmaceuticals USA and Sandoz Inc.
|
Pending |
| 02/10/2006 |
2006P-0071 |
Regulatory & Clinical Research Institute, Inc (RCRI)/513
(e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
|
Interim Response 08/23/2006 |
| 02/10/2006 |
2006P-0072 |
Olsson,Frank and Weeda, P.C./ANDA for prednisolone sodium
phosophate, USP,oral solution, 10 mg prednisolone base/5mL |
Withdrawn 03/30/2006 |
| 02/13/2006 |
2006V-0073 |
Adventure Zone/Projector for a Laser Light Show |
Approved 05/24/2006 |
| 02/13/2006 |
2006P-0074 |
Lachman Consultant Services, Inc./Determine whether Doxycycline
Tablets, 75 mg (ANDA 65-070), held by Par Pharmaceuticals has
been voluntarily withdrawn from sale for safety or efficacy
reasons
|
Withdrawn 04/19/2006 |
| 02/15/2006 |
2006P-0069 |
The Quaker Oats Company/Health Claim Petition: Soluble Fiber
from Certain Foods and Coronary Heart Disease
|
Pending |
| 02/15/2006 |
2006V-0076 |
Renishaw/Laser Light Show |
Pending |
| 02/16/2006 |
2006P-0077 |
Pfizer Inc./Refrain from lifting the administrative stay for
amlodipine maleate tablets (NDA 21-435) until after September
25, 2007 |
Interim Response 08/14/2006 |
| 02/22/2006 |
2006P-0084 |
King & Spalding/ANDA Suitability for 1.25 mg, 2.50 mg,
5 mg, and 10 mg Ramipril Tablets |
Pending |
| 02/22/2006 |
2006P-0085 |
American Association of Neurological Surgeons/To Exempt the
Class II device Cranial Orthoses from Premarket Notification
Requirements |
Pending |
| 02/23/2006 |
2006P-0086 |
Lachman Consultant Services, Inc. /To declare that the drug
product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets,
is suitable for consideration in an abbreviated new drug application
(ANDA) |
Approved 08/18/2006 |
| 02/24/2006 |
2006P-0087 |
Lachman Consultant Services, Inc./To declare that the drug
product, Propoxyphene Napsylate, 50 mg and Acetaminophen, 300
mg tablets are suitable for consideration in an abbreviated
new drug application (ANDA) |
Pending |
| 02/27/2006 |
2006P-0089 |
Korein Tillery LLC/Stay approval of all supplements to biologics
licenses issued to Genentech (BLA# 103705) and Biogen (BLA#
103737) for Rituxan (Rituximab) |
Interim Response 08/28/2006 |
| 02/28/2006 |
2006P-0090 |
Public Citizen's Health Research Group/Immediately begin the
phased removal from the market of propoxyphene (Darvon) and
all propoxyphene-containing products. |
Interim Response 08/22/2006 |
| 02/28/2006 |
2004P-0513 |
Beth Rosenshein/to amend regulation update 'Estrogens Increase
The Risk of Endometrial Cancer prescribing info of all strengths
of Premarin tablets |
Pending |
| 02/28/2006 |
2006P-0094 |
The Sugar Association/To undertake rulemaking to establish
specific rules and regulations governing the definition of natural
before a natural claim can be made on foods and beverages regulated
by the FDA
|
Interim Response 09/11/2006 |
| Top |
| March |
| 03/01/2006 |
2006P-0092 |
Amphastar Pharmaceuticals, Inc./Determine that Astra Zeneca's
Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford
Laboratories Propofol Injectable Emulsion are misbranded
|
Interim Response 08/22/2006 |
| 03/01/2006 |
2006P-0093 |
ECO Animal Health/ECOAnimal Health seeks permission to file
an ANADA for a generic equivalent of the innovator product Ivomec
(ivermectin) injection for cattle and swine , 1% sterile solution
NADA 128- 409, Merial LTD.,
|
Denied 05/05/2006 |
| 03/02/2006 |
2006P-0095 |
Sandoz, Inc./ANDA suitability for a Piperacillin and Tazobactam
for Injection, 13.5 g pharmacy bulk vial |
Pending |
| 03/02/2006 |
2006P-0098 |
Monosol Rx, LLC/Seeks a determination that Loperamide hydrochloride
2 mg orally dissolving film strip is suitable for an ANDA based
on the reference listed drug loperamide hydrochloride 2 mg oral
chewable tablet (Imo
|
Withdrawn 05/01/2006 |
| 03/03/2006 |
2006P-0096 |
Monterey Mushrooms Inc./Regarding the following non-binding
package requirement for a minimum of - 1/8 inch holes in each
package of mushrooms |
Interim Response 11/03/2006 |
| 03/03/2006 |
2006V-0097 |
Night Vision Equipment Co./Laser Light Show |
Pending |
| 03/07/2006 |
2006P-0101 |
American Beekeeping Federation, Inc. et al/Petition for Review
of Codex Standard for Honey Under 21 CFR 130.6 |
Interim Response 08/31/2006 |
| 03/08/2006 |
2006P-0102 |
Lord Bissell Brook/Take appropriate remedial action relating
to an apparent safety issue regarding Bellatal ER
|
Interim Response 09/05/2006 |
| 03/09/2006 |
2006P-0103 |
Lachman Consultant Services, Inc./Declare that Temazepam Orally
Disintegrating Tablets, 7.5 mg, 15 mg, 22,5 mg, and 30 mg is
suitable for submission as an ANDA. |
Withdrawn 03/29/2007 |
| 03/14/2006 |
2006V-0110 |
Granger Community Church/ Laser Display Device |
Pending |
| 03/15/2006 |
2006V-0111 |
Aurora Projections/Projector for a Laser Light Show |
Approved 06/28/2006 |
| 03/15/2006 |
2006P-0114 |
Foley & Lardner LLP/Refrain from taking administrative
action regarding approval and/or effective date of final approval
of any and all ANDAs for a generic version of Metrogel-Vaginal
0.75% |
Interim Response 09/11/2006 |
| 03/15/2006 |
2006P-0117 |
QPharma, LLC/Declare that Omeprazole Tablets, 20 mg (proposed
formulation), is suitable for submission as an ANDA |
Pending |
| 03/15/2006 |
2006V-0119 |
Mero Productions/Laser Light Show |
Pending |
| 03/16/2006 |
2006P-0120 |
EnviroWatch, Inc./Enforce ban on carbon monoxide in the packaging
of fresh tuna and fresh tuna that is subsequently frozen |
Pending |
| 03/17/2006 |
2006P-0122 |
Lachman Consulant Services, Inc./ANDA Suitability for Cetirizine
Hydrochloride Orally Disintegrating Tablets, 5 mg and 10 mg |
Pending |
| 03/17/2006 |
2006P-0123 |
Mylan Laboratories Inc./Request that all applicants for fentanyl
transdermal systems conduct a study to support the safe of an
overly with their repective fentanyl transdermal products |
Interim Response 09/11/2006 |
| 03/17/2006 |
2006P-0124 |
ViroPharma/Stay any approvals of an Abbreviated New Drug Application
(ANDA) for Vancocin Capsules |
Pending |
| 03/20/2006 |
2006P-0125 |
Lachman Consultant Services, Inc./Determine whether Dexedrine
(dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been
voluntarily withdrawn from sale for safety or efficacy reasons |
Interim Response 09/13/2006 |
| 03/20/2006 |
2006P-0126 |
Richard S. Wyde, Esq. & Roberta Kraus Wyde, MPH, PhD/Take
specific actions with regard to the animal product that is manufactured
by S&M NuTec LLC known as a "Greenie"
|
Interim Response 08/25/2006 |
| 03/21/2006 |
2006N-0100 |
Center for Desease Control and Prevention/Medical Devices;
Immunology and Microbiology Devices; Classification of Reagents
for Detection of Specific Novel Influenza A Viruses |
Pending |
| 03/22/2006 |
1976N-0052N |
Number not used/OTC Nasal Decongestants |
Pending |
| 03/24/2006 |
2006P-0129 |
number not used/Number not used |
Pending |
| 03/24/2006 |
2006P-0131 |
AAC Consulting Group/ANDA Suitability for Epirubicin Hydrochloride
Injection, 2mg/ mL vial sizes of 10 mg/ 5 mL, 20 mg/ 10 mL and
200 mg/ 100 mL |
Pending |
| 03/24/2006 |
2004P-0457 |
Endotec, Inc./Reclassifcation of the Buechel-Pappas Unconstrained
Ankle Prosthesis |
Interim Response 04/11/2006; Answer 08/23/2007 |
| 03/27/2006 |
2006V-0134 |
Fun City LLC/Laser Light Show |
Pending |
| 03/27/2006 |
1981N-0022 |
Wyeth/OTC Weight Control Drug Products for Human Use |
Interim Response 09/25/2006 |
| 03/27/2006 |
1976N-0052N |
Wyeth/OTC Nasal Decongestants |
Interim Response 09/25/2006 |
| 03/27/2006 |
2006P-0135 |
National Coalition for Cancer Survivorship and American Society
of Clinical Oncology/Issue Guidance to Industry outlining procedures
and standards for initiating an "expanded access program"
for unapproved drugs |
Pending |
| 03/27/2006 |
2006P-0140 |
Connetics Corporation/To withhold approval of any ANDA for
a generic version of acitretin capsules |
Interim Response 09/15/2006 |
| 03/27/2006 |
2006V-0141 |
Mathew Raftery/Laser Light Show |
Pending |
| 03/27/2006 |
2006V-0142 |
XENO13 - Phantom Dynamics/Laser Light Show |
Pending |
| 03/27/2006 |
2006V-0143 |
Pro Video Solutions, Inc./Laser Light Show |
Approved 05/04/2006 |
| 03/30/2006 |
2006P-0124 |
ViroPharma Incorporated/Stay any approvals of an Abbreviated
New Drug Application (ANDA) for Vancocin Capsules |
Pending |
| 03/30/2006 |
2006P-0144 |
Custopharm, Inc./delalutin hydroxyprogesterone caproate) Injection
was not withdrawn for safety or effectiveness reasons and therefore
suibable for ANDA |
Interim Response 09/22/2006 |
| 03/31/2006 |
2006P-0145 |
Lachman Consultant Services, Inc./ANDA suitability for Gemcitabine |
Approved 08/22/2007 |
| 03/31/2006 |
2006P-0146 |
Coalition for Healthcare Communication/Request for Promulgation
of an Amended Regulation for |
Pending |
| 03/31/2006 |
2006P-0147 |
Lachman Consultant Services, Inc./Determine whether Risperdal
M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and
4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld
from sale for safety or efficacy reasons |
Withdrawn 06/28/2006 |
| Top |
| April |
| 04/05/2006 |
1981N-0033 |
The Procter & Gamble Company/Oral Health Care Drug Products
for OTC Human Use |
Pending |
| 04/05/2006 |
2006V-0153 |
Palomar Medical Technologies, Inc./Variance for Hair Removal
System |
Approved 06/09/2006 |
| 04/07/2006 |
2006P-0137 |
Ocean Nutrition Canada, Ltd/Nutrient Content Claim for EPA
and DHA omega-3 fatty acids |
Interim Response 11/27/2007 |
| 04/07/2006 |
2006P-0158 |
Citizens for Health/Revoke regulations that provided for the
inclusion and addition of sucralose as a non-nutritive sweetener
in food |
Pending |
| 04/10/2006 |
2006P-0151 |
Chemically Associated Neurological Disorders/Stay the current
approvable letter with conditions of any and all Premarket Applications
for silicone gel-filled breast implants |
Denied 11/17/2006 |
| 04/10/2006 |
2006P-0154 |
Public Citizen/remove from the market, the prescription version
of Xenical (orlistat,Roche Pharmaceuticals) |
Denied 02/07/2007 |
| 04/11/2006 |
2006V-0155 |
Club Rabie, Inc/Laser Light Show |
Approved 06/26/2006 |
| 04/11/2006 |
2006V-0156 |
The Rhythm System/Projector for a Laser Light Show |
Pending |
| 04/11/2006 |
2006P-0159 |
James Q. Maloy/Recommend changes to NIST Handbook 44 (through
the NIST and NCWM), and the U.S. Pharmacopeia to reflect the
required pharmacy quality control practices |
Denied 07/25/2006 |
| 04/13/2006 |
2006P-0160 |
Taro Research Institute/Request ANDA Suitability of Dichlorphenamide
Tablets USP, 50 mg, |
Interim Response 10/04/2006 |
| 04/18/2006 |
2006V-0164 |
MGM Productions, Inc./Laser Light Show |
Approved 07/13/2006 |
| 04/18/2006 |
2006P-0165 |
Banner & Witcoff, Ltd./Initiate administrative proceedings
for the purpose of investigating and enjoining the unlawful
sale and distribution by International Tan Makers, Inc., of
ultraviolet suntanning lamps that are misbr |
Answer 10/04/2006 |
| 04/20/2006 |
2006P-0167 |
Arnall Golden Gregory LLP/ANDA Suitability for Oxycodone and
Acetaminophen drug product in an orally disintigrating form |
Pending |
| 04/20/2006 |
2006P-0167 |
Arnall Golden Gregory LLP/ANDA Suitability for Oxycodone and
Acetaminophen drug product in an orally disintigrating form |
Pending |
| 04/24/2006 |
2006V-0171 |
Edge Innovations/Laser Light Show |
Pending |
| 04/25/2006 |
2006P-0173 |
Wyeth Pharmaceuticals/Request approval of any abbreviated
new drug application relying on Zosyn (piperacillin and tazobactam
for injection) as its reference product be contingent upon the
proposed product |
Interim Response 10/19/2006 |
| 04/26/2006 |
2006P-0174 |
NitroMed, Inc./FDA to determine that any drug is therapeutically
equivalent or AB-rated to BiDil (isosorbide dinitrate and hydralazine
hydrochloride |
Withdrawn 04/28/2006 |
| 04/26/2006 |
2006V-0153 |
Palomar Medical Technologis, Inc./Variance for Hair Removal
System |
Pending |
| 04/27/2006 |
2006V-0175 |
Haygood Entertainment/Laser Light Show |
Approved 06/01/2006 |
| Top |
| May |
| 05/01/2006 |
2006P-0177 |
Sicor Pharmaceuticals, Inc./Suitability for Methotrexate |
Withdrawn 02/20/2007 |
| 05/01/2006 |
2006P-0178 |
Public Citizen's Health Research Group/Immediately ban fluoroquinolone
antibiotic gatifloxacin in humans |
Interim Response 10/27/2006 |
| 05/02/2006 |
2006P-0179 |
Y. Kim/Ban of Carcinogenic Potassium Bromate |
Interim Response 12/04/2006 |
| 05/04/2006 |
2006P-0186 |
Charles R. Nolan, M.D/Withdraw new drug application (NDA 21-179)
for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg |
Interim Response 10/27/2006 |
| 05/05/2006 |
2006V-0188 |
Village Group International/Club Metropolis/Laser Light Show |
Approved 05/22/2006 |
| 05/08/2006 |
2006V-0192 |
New Life Church/Laser Light Show |
Approved 05/22/2006 |
| 05/09/2006 |
2006V-0194 |
Funzalosound/Laser Light Show |
Closed 05/09/2006 |
| 05/09/2006 |
2002V-0183 |
Funzalosound/Laser Light Show |
Pending |
| 05/10/2006 |
2006P-0195 |
Rakoczy Molino Mazzochi Siwik LLP/Determine that Wyeth Pharmaceuticals,
Inc. discontinued its original formulation of Zosyn (piperacillin
and tazobactam) for reasons unrelated to safety and efficacy
and to allow companies to file Abbr
|
Interim Response 11/02/2006 |
| 05/10/2006 |
2006P-0196 |
West-Ward Pharmaceutical, Corp./ANDA for Lithium Carbonate
Tablets, 300 mg (NDA 016834) |
Withdrawn 08/11/2006 |
| 05/11/2006 |
2006P-0201 |
B. Braun Medical Inc./Cefotan (cefotetan injection), equivalent
1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been
voluntarily withdrawn from sale for safety and efficacy reasons
|
Interim Response 11/02/2006 |
| 05/12/2006 |
2006P-0205 |
Rutgers, The State University Of New Jersey/Require Vitamin
D be added to cereal-grain products |
Pending |
| 05/15/2006 |
2006P-0207 |
Strides Inc./ANDA Suitability for Cetirizine Hydrochloride
Soft Gelatin Capsules 5mg and 10mg |
Pending |
| 05/15/2006 |
2006P-0208 |
Strides, Inc./Permit the filing of an ANDA for Loratadine
Soft Gelatin Capsules 10mg |
Pending |
| 05/16/2006 |
2006P-0209 |
Lachman Consultant Services, Inc./Safety or Efficacy of Diastat
(diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20
mg/4 ml |
Interim Response 11/13/2006 |
| 05/17/2006 |
2006P-0210 |
The International Center for Technology Assessment/Petition
requesting FDA amend its regulations for products composed of
engineered nanoparticles generally and sunscreen drug products
composed of engineered nanoparticles specifically |
Interim Response 11/09/2006 |
| 05/17/2006 |
1978N-0038 |
The International Center for Technology Assessment/Sunscreen
Drug Products |
Pending |
| 05/17/2006 |
2006P-0212 |
Michael Patterson/Lasik due to the use of research from experiments
conducted on human beings without proper basis to believe it
is in the patients best interests and improper patient informed
consent |
Denied 07/20/2007 |
| 05/17/2006 |
2006P-0213 |
Michael Patterson/enforce the single-use requirement for all
Microkeratomes and their components used by Lasik |
Denied 07/20/2007 |
| 05/23/2006 |
2006V-0216 |
UniversalStudios Florida/Laser Light Show |
Approved 07/05/2006 |
| 05/23/2006 |
2006V-0217 |
Soundex Information Systems, Inc./Laser Light Show |
Pending |
| 05/24/2006 |
2006P-0218 |
West-ward Pharmaceutical Corp./ To permit an abbrevation New
Drug Application Triamcinolone Diacetate Suspension |
Interim Response 11/20/2006 |
| 05/26/2006 |
2006P-0223 |
State of Wisconsin Department of Justic/swith Plan B and equivalent
EC drugs from prescription-only to OTC status without age restrictions,
exempt from prescription -dispensing requirement any new drug
eligible for filing an ANDA because of |
Interim Response 11/20/2006 |
| 05/26/2006 |
2006P-0224 |
Pfizer Inc./Take appropriate remedial action against the apparent
misbranding of generic azithromycin marketed by Pliva, Inc. |
Interim Response 11/20/2006 |
| Top |
| June |
| 06/02/2006 |
2006P-0093 |
ECO Animal Health/ECOAnimal Health seeks permission to file
an ANADA for a generic equivalent of the innovator product Ivomec
(ivermectin) injection for cattle and swine , 1% sterile solution
NADA 128- 409, Merial LTD.,
|
Pending |
| 06/02/2006 |
2006V-0227 |
Kiamesha Lanes/Request for Laser Light Show Projector |
Approved 08/11/2006 |
| 06/06/2006 |
2006P-0230 |
Kamins Dermatologics, Inc./Abbrevation New Drug Application
Suitability for Lidocaine Hydrochloride |
Pending |
| 06/06/2006 |
2006P-0241 |
Zydus Pharmaceuticals Inc/Appeal District Court Civil Action
No. 05-1838 (RWR) and deny the citzen petitions of Ivax and
Ranbaxy |
Pending |
| 06/09/2006 |
2006P-0242 |
AstraZeneca LP (AstraZeneca)/Approval of any Budesonide Inhalation
Suspension Product using Pulmicort Respules |
Interim Response 12/04/2006 |
| 06/09/2006 |
2001P-0075 |
FDA to Center for Reproductive Rights/Switch Status of Emergency
Contraceptives from Rx to OTC |
Pending |
| 06/09/2006 |
2006FL-0238 |
International Media and Cultures (IMAC)/Food Allergen Labeling
Petition (FALP): Culture Media with Enzyme-Treated Soy Solids |
Pending |
| 06/13/2006 |
2006V-0244 |
Cypress Gardens/Laser Light Show |
Approved 06/26/2006 |
| 06/13/2006 |
2006P-0245 |
Mylan Pharmaceuticals, Inc./Exclusivity Determination for
Risperidone |
Interim Response 12/15/2006; Withdrawn 06/28/2007 |
| 06/13/2006 |
2006P-0249 |
Bayer HealthCare /Refain from approving all abbreviated applications
for generic enrofloxacin that purport to copy Bayer's Baytril
100 Injectable Solution |
Interim Response 12/08/2006 |
| 06/15/2006 |
2006V-0248 |
Independence High-SpaceScience Tech Magnet/Laser Light Show |
Approved 06/26/2006 |
| 06/15/2006 |
2006P-0251 |
Maya F. Perrott/Label change or removal from the market of
the psychotropic drug Depakote |
Denied 09/20/2006 |
| 06/16/2006 |
2006P-0243 |
ACH Food Companies, Inc./Qualified Health Claim: (QHC) : Corn
oil and corn oil containing foods and heart disease |
Interim Response 06/16/2006; Answer 03/26/2007 |
| 06/16/2006 |
2006P-0253 |
AAC Consulting Group/ANDA Suitability for Loperamind Hydrochloride |
Pending |
| 06/19/2006 |
2006P-0256 |
Number Not Used/See 78n-0038 CP18 |
Pending |
| 06/19/2006 |
1978N-0038 |
Schering-Plough Consumer Healthcare/Sunscreen Drug Products |
Interim Response 12/08/2006 |
| 06/20/2006 |
2006P-0255 |
Orchid Healthcare (A Division of Orchid Chemicals & Pharmaceuticals
Ltd)/discontinued formulation of Warner Chilcott's Duricel (cefadroxil)
tablets 1 g was not discontinued for safety and efficacy reasons |
Interim Response 12/14/2006; Answer 03/28/2007 |
| 06/20/2006 |
2006V-0257 |
Bart Rocket Theatre/Laser Light Show |
Pending |
| 06/20/2006 |
2006P-0258 |
Zydus Pharmaceuticals (USA) Inc./Immediately approve ANDA
No. 77-837 upon the June 23, 2006 patent expiration of U.S.
Patent No. 4,444,784 |
Pending |
| 06/21/2006 |
2006P-0263 |
Sparhawk Laboratories, Inc/ANADA suitability for Neomycin |
Approved 09/06/2006 |
| 06/22/2006 |
2006P-0265 |
Lupin Pharmaceuticals, Inc./to permit an ANDA Suitability
for Cefdinir |
Pending |
| 06/26/2006 |
2006P-0267 |
Lachman Consultant Services, Inc./to permit an ANDASuitability
for Dextroamphetamine Sulfate Tablets |
Approved 03/20/2007 |
| 06/26/2006 |
2006P-0271 |
Clinical and Laboratory Standards Institute/Amend practice
of assessing the performance of medical devices for determining
in vitro susceptibility of bacteria or fungi to included CLSI. |
Approved 03/05/2007 in part and denied in part |
| 06/27/2006 |
2006V-0269 |
Saginaw Spirit/Laser Light Show |
Approved 08/25/2006 |
| 06/27/2006 |
2006V-0270 |
Rocky Mount Children's Museum/Laser Light Show |
Approved 08/25/2006 |
| Top |
| July |
| 07/03/2006 |
2006P-0272 |
Beckloff Associates, Inc./ANDA Suitability for 0.9% Sodium
Chloride Injection |
Approved 08/23/2007 |
| 07/03/2006 |
2006P-0273 |
Beckloff Associates/ANDA for Water for Injection, USP, in
3-, 5-, 15-, and 30-mL volumes |
Approved 08/22/2007 |
| 07/06/2006 |
2006P-0085 |
American Association of Neurological Surgeons/To Exempt the
Class II device Cranial Orthoses from Premarket Notification
Requirements |
Pending |
| 07/12/2006 |
2006P-0280 |
Public Citizen Litigation Group/Emergency Request to Open
Blood Products Advisory Committee Meeting on Friday, July 14,
2006 |
Withdrawn 07/27/2006 |
| 07/12/2006 |
2006P-0281 |
Camargo Pharmaceutical Services, LLC/Determination of Orudis
KT (ketoprofen, 12.5 mg) Oral Tablet |
Closed 08/16/2007 |
| 07/14/2006 |
2006P-0285 |
Duramed Research, Inc./Refrain from Granting any Bioequivalence
Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale |
Interim Response 01/12/2007 |
| 07/17/2006 |
2006P-0286 |
Lachman Consultant Services, Inc./Determine Whether Phoslo
(calcium acetate) Capsules eq169 mg calcium have been voluntarily
withdrawn from sale for safety or effcacy reasons. |
Withdrawn 08/28/2006 |
| 07/17/2006 |
2006P-0287 |
Lachman Consultant Services, Inc./determine Whether Phoslo
(calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily
withdrawn from sale for safety or efficacy reasons |
Closed 07/30/2007 |
| 07/19/2006 |
2006P-0288 |
Beckloff Associates/Permit an ANDA Suitability for Alprazolam |
Pending |
| 07/19/2006 |
2006V-0289 |
Bliss Nashville LLC/Laser Light Show |
Approved 08/25/2006 |
| 07/24/2006 |
2006P-0290 |
Mylan Laboratories Inc./Risk Management Program for Fentanyl
Products |
Interim Response 01/22/2007 |
| 07/24/2006 |
2006P-0299 |
Rothwell, Figg, Ernst & Manbeck, P.C./Determine whether
Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile
lyophilized powder vials (NDA #21-492 has been withdrawn for
safety or effectiveness reasons |
Interim Response 01/22/2007; Answer 11/26/2007 |
| 07/25/2006 |
2006P-0291 |
Sicor Pharmaceuticals, Inc./Determine whether Eloxatin (Oxaliplatin)
has been voluntarily withdrawn or withheld from sale for safety
or efficacy reasons |
Interim Response 01/22/2007; Answer 11/26/2007 |
| 07/25/2006 |
2006P-0298 |
AAC Consulting Group/To permit an ANDA Suitability for Eloxatin
(Oxaliplatin for injection) |
Interim Response 01/22/2007; Answer 11/26/2007 |
| 07/28/2006 |
2006P-0300 |
Lachman Consultant Services Inc./ANDA Suitability for Glycoprrolate
Tablets, USP 1.5 mg |
Answer 03/20/2007 |
| 07/31/2006 |
2006P-0302 |
Beckloff Associates/Permit the filing of an ANDA Suitability
for Sodium Chloride Injection |
Approved 08/22/2007 |
| Top |
| August |
| 08/02/2006 |
2006V-0304 |
Hart Entertainment/Laser Light Show |
Pending |
| 08/02/2006 |
2006P-0305 |
Monosol Rx, LLC./Permit the Filing of an ANDA Suitability
for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg |
Pending |
| 08/02/2006 |
2006P-0307 |
University of California/To amend 21CFR 201.17 regarding expiration
dates |
Interim Response 01/25/2007 |
| 08/03/2006 |
2006P-0306 |
The States of Kansas, Minnesota, Vermont and Wisconsin/Publish
specific requirements for applications seeking approval to market
therapeutically equivalent versions of insulin and human growth
hormone
|
Interim Response 01/30/2007 |
| 08/07/2006 |
2006P-0309 |
Frommer, Lawrence & Haug, LLP/ANDA for ELOXATIN (oxaliplatin
for injection) lyophilized powder for infusion, 50 mg and 100
mg vials |
Interim Response 02/02/2007; Answer 11/26/2007 |
| 08/07/2006 |
2006P-0310 |
Peiser & Associates Inc./Compel the Agency to follow requirements
of the Drug Listing Act of 1972 |
Interim Response 02/02/2007 |
| 08/07/2006 |
2006P-0311 |
Foley & Lardner LLP/Investigate and take regulatory action
to protect surgical patients from a potential significant safety
risk in connection with Propofol Injectable Emulsion marketed
by Bedford Laboratories |
Interim Response 02/02/2007 |
| 08/07/2006 |
2006P-0313 |
Bayer Corporation/Removal of labeling for MediSense Precision
Advanced Diabetes Management System |
Withdrawn 09/06/2006 |
| 08/08/2006 |
2006V-0317 |
Linden Laser Systems/Laser Light Show |
Pending |
| 08/10/2006 |
2006A-0318 |
Ropes & Gray/Request for Advisory Opinion Concerning Orange
Book Listing of Patents |
Interim Response 02/02/2007 |
| 08/11/2006 |
2006P-0319 |
Washington Legal Foundation/Regarding review of policies and
practices of DDMAC and OCBQ to ensure compliance with first
amendment and statutory mandate |
Interim Response 02/07/2007 |
| 08/17/2006 |
2006P-0334 |
Regeneration Technologies, Inc./Reclassification Petition
fo Bone Heterografts |
Interim Response 10/25/2007 |
| 08/18/2006 |
2006V-0337 |
Blazer Laser Safety, Inc/Variance for Laser Product "Life
Beam Extreme" |
Pending |
| 08/18/2006 |
2006P-0316 |
Unilever United States, Inc/Health Claim: Phyposterols and
Reduced Risk of Coronary Heart Disease |
Pending |
| 08/22/2006 |
2006P-0346 |
National Women's Health Network/Ban Marketing of Estratest,
Estratest H.S. and Syntest D.S. and Syntest H.S. associated
with Menopause |
Interim Response 02/12/2007 |
| 08/24/2006 |
2006P-0348 |
Clinical and Laboratory Standards Institute/Amend the vancomycin
HCl package insert to reflect modifications of the antimicrobial
susceptibility interpretive criteria to better recognize emerging
resistance resulting in compromised patient outc |
Pending |
| 08/28/2006 |
2006P-0364 |
J. Kulli, M.D./Reformulation of central nervous system (CNS)
stimulant drugs |
Pending |
| 08/29/2006 |
2006P-0360 |
Hospira Inc./Determine that the discontinued formulation of
Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not
discontinued for safety and efficacy reasons |
Pending |
| 08/29/2006 |
2006P-0359 |
Number not used/Number not used (see 2006P-0319) |
Pending |
| 08/29/2006 |
2006P-0361 |
Rakoczy Molino Mazzochi Siwik, LLP/Deny Request to switch
ketotifen fumarate ophthalmic solution, 0.025% |
Withdrawn 11/14/2006 |
| Top |
| September |
| 09/05/2006 |
2006P-0365 |
Kerr Corporation/Urge FDA to Take Regulatory Action to Safeguard
the Public from Violative Dental Devices Distributed by Five
Companies, Including Devices Manufactured in Unregistered Facilities
and |
Answer 01/08/2007 |
| 09/06/2006 |
2006P-0351 |
Diplomate of the American Board of Internal Medicine &
Nephrology Fulbright Scholar in Medicine/Restriction or withdrawal
of the use of angiotensin converting enzyme inhibitor (ACEI)
and angiotensin receptor blocker (ARB) therapy in the following
conditions |
Interim Response 03/01/2007 |
| 09/06/2006 |
2006P-0370 |
Public Citizen/Revoke FDA's prior approval of vagus nerve
stimulation (VNS) for mangement of treatment-resistant depression
(TRD) |
Pending |
| 09/07/2006 |
2006P-0369 |
Kirkpatrick & Lockhart Nicholson Graham LLP/ANDA Suitability
for Alclometasone Dipropionate Lotion, 0.05% |
Pending |
| 09/08/2006 |
2006P-0371 |
Public Citizen's Health Research Group/Immediately add a black
box warning regarding the risks of tendinopathy and tendon rupture
to the product labels of all fluoroquinolone antibiotics presently
on the market in the United States |
Pending |
| 09/08/2006 |
2006P-0372 |
Lachman Consultant Services, Inc./Determine whether Mepron
(atovaquone) Tablets, 250 mg, has been voluntarily withdrawn
from sale for safety or efficacy reasons |
Interim Response 03/07/2007; Answer 05/16/2007; Closed 05/16/2007
LET 2 6/1/07 |
| 09/11/2006 |
2006V-0373 |
Griffith Observatory, (Oschin Planetarium)/Laser Light Show |
Pending |
| 09/11/2006 |
2006P-0375 |
John D. Stephens, M.D./Banning of Urogender Test |
Withdrawn 10/12/2006 |
| 09/11/2006 |
2006P-0376 |
John D. Stephens, M.D./Banning of Acu-Gender Blood Test |
Withdrawn 10/12/2006 |
| 09/12/2006 |
2006V-0377 |
Evans & Sutherland Computer Corporation/Laser Light Show |
Pending |
| 09/12/2006 |
2006P-0379 |
The George Washington University Medical Center/To urge the
FDA 's prompt action to cancel the GRAS desgnation for diacetyl |
Interim Response 06/25/2007 |
| 09/15/2006 |
2006P-0387 |
Paddock Laboratories/Declare That Clobetasol Propionate from,
0.05% is suitable for submission in an ANDA |
Pending |
| 09/18/2006 |
2006V-0388 |
Martin Professional Inc./Projector for a Laser Light Show |
Pending |
| 09/18/2006 |
2002F-0316 |
Food & Water Watch/Safe Use of Mix of Bacteriofages/Antimicrobial
Agent |
Pending |
| 09/19/2006 |
2006P-0390 |
Jerry Staton/Order the Church of Scientology to clearly disclose
the potential health hazards inherent in the use of the E-meter
and Scientology's practice of "auditing" |
Interim Response 03/16/2007 |
| 09/22/2006 |
2006P-0392 |
Valeant Pharmaceuticals International (Valeant)/ANDA for
a Diazepam Rectal Gel that Relies on Diastat 5 mg/mL, 10 mg/2mL,
15 mg/3 mL or 20 mg/mL |
Interim Response 03/20/2007 |
| 09/27/2006 |
2006P-0394 |
Compassion Over Killing, Inc./Revise the labeling requirements
for eggs sold in the United States |
Pending |
| 09/27/2006 |
2006P-0395 |
Kendle International/To permit an ANDA Suitability for Metoprolol
Tartrate Tablets |
Pending |
| 09/28/2006 |
2006P-0393 |
Cargill, Incorporated/Health Claim Petition; Barley Betafiber
and Cornary Heart Disease |
Pending |
| 09/28/2006 |
2006P-0399 |
Beckloff Associates/To determine whether PhosLo (calcium
acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate)
Capsules, eq 169 mg calcium, has been withdrawn for safety or
efficacy reasons |
Closed 07/30/2007 |
| 09/29/2006 |
2006P-0397 |
Lupin Pharmaceuticals, Inc./Permit an ANDA Suitability for
Fexofenadine Hydrochloride for Oral Suspension |
Pending |
| 09/29/2006 |
2006P-0398 |
Frommer Lawrence & Haug, LLP/Require bioequivalence studies
for generic or follow-on formulations of MEGACE ES (megestrol
acetate oral suspension 625 mg/5 ml) |
Interim Response 03/20/2007 |
| 09/28/2006 |
2006P-0402 |
Washington Legal Foundation (WLF)/FDA would not regulate
as Medical Device Assays Developed by Clinical Laboratories
strictly for in-house use (home brew) |
Pending |
| 09/29/2006 |
2006V-0401 |
Superimaging Inc and AP Marketing Development/Laser Display
Device |
Pending |
| Top |
| October |
| 10/02/2006 |
2006P-0404 |
B. Braun Medical, Inc./Determine Whether Cefotan (Cefotetan
Injection) has been Voluntarily Withdrawon from the Sale for
Safety and Efficacy Reasons |
Interim Response 03/26/2007 |
| 10/03/2006 |
2006P-0403 |
B. Braun Medical Inc./Determine whether an Abbreviated New
Drug Application can be filed against the listed drug Novamine
15%, manufactured by Hospira under NDA 17-957 |
Withdrawn 03/27/2007 |
| 10/03/2006 |
2006P-0405 |
UCB, Inc/Require full prescribing information of all antiepileptic
drugs contain specific language under Warnings or Warnings and
Precautions |
Interim Response 04/02/2007 |
| 10/05/2006 |
2006P-0406 |
Pfizer Inc./Take appropriate remedial action against the
apparent misbranding of generic azithromycin for oral suspension
marketed by Pliva, Inc. |
Interim Response 03/26/2007 |
| 10/10/2006 |
2006P-0410 |
MedImmune Oncology, Inc./Refuse to approve any ANDA for amifostine
product with labeling which omits dosage and other information |
Interim Response 04/02/2007 |
| 10/12/2006 |
2006P-0415 |
Center for Food Safety/Petition Seeking Regulation of Cloned
Animals |
Pending |
| 10/16/2006 |
2006P-0417 |
Lachman Consultant Services, Inc./to permit an ANDA Suitability
for Doxycycline Monohydrate Tablets |
Pending |
| 10/18/2006 |
2001E-0213 |
Generamedix Pharmaceuticals, Inc./Angiomax, Patent Term Extension
Application, No. 5,196,404 |
Withdrawn 01/03/2007 |
| 10/18/2006 |
2006P-0422 |
KV Pharmaceutical Company/Refrain from approval of any ANDA
for metoprolol succinate extended release 100 mg and 200 mg
tablets subsequent to ANDA 76-640 from KV Pharmaceutical |
Denied 12/12/2007; Closed 12/12/2007 |
| 10/19/2006 |
2006FL-0384 |
The Solae Company/Food Allergen Labeling Petition (FALP):
Soy lecithin when used as processing aids |
Pending |
| 10/19/2006 |
2006P-0423 |
Pharmacists Planning Service, Inc. et al/Regulate Labeling
and Packaging of Acetaminophen/APAP Containing Products |
Pending |
| 10/20/2006 |
2006V-0424 |
RPI Entertainment & Media Group/Projector for a Laser
Light Show |
Pending |
| 10/23/2006 |
2006P-0428 |
Boehringer Ingelheim Pharmaceuticals, Inc./Combivent (ipratropium
bromide and albuterol sulfate) |
Interim Response 04/20/2007 |
| 10/24/2006 |
2004P-0349 |
CoMeD, Coalition for Mercury-Free Drugs/Action on Products
containing added Mercury |
Answer 12/21/2006 |
| 10/24/2006 |
2006V-0429 |
The Den- DenNightClub/Projector for a Laser Light Show |
Pending |
| 10/24/2006 |
2006P-0535 |
CoMed, Coalition for Mercury-Free Drugs/Ban From all Medicine
and Vaccines Thimerosal or any Other Mercury-based Compound
Products |
Answer 03/28/2007 |
| 10/26/2006 |
2006P-0437 |
Mediscovery, Inc./To Permit the Filing of an ANDA Suitability
Petition for Paclitaxel, USP. |
Pending |
| 10/26/2006 |
2006P-0438 |
Olsson, Frank and Weeda, P.C./ANDA for Betamethasone Valerate
Foam (non-aerosol), 0.12% |
Pending |
| 10/26/2006 |
2006P-0444 |
Schwarz Pharma, Inc./Stay the potential grant effective approval
of ANDA for 77-536 for moexipril hydrochloride tablets |
Answer 12/06/2006 |
| 10/27/2006 |
2006V-0440 |
Hyperfomance Audio Productions/Laser Light Show |
Pending |
| 10/27/2006 |
2007P-0085 |
Grocery Manufacturers Association /Adopt Regulations of General
Applicability to all Food Standards that would Permit Deviations
from the Requirements of the Individual Food Standards of Identity |
Pending |
| 10/30/2006 |
2006P-0442 |
Orchid Healthcare/Determine that Wyeth Pharmaceuticals, Inc.
discontinued its previously-approved formulation of the Reference
Listed Drug Zosyn (piperacillin and tazobactam for injection),
40.5 gram pharmacy bulk via |
Interim Response 04/23/2007 |
| 10/30/2006 |
1995N-0294 |
Grocery Manufacturers Association/Quality/fill container;
common or unusual name regulations |
Closed 02/22/2007 See Docket 2007P-0085 |
| 10/30/2006 |
2006V-0447 |
Electric Cowboy/Laser Light Show |
Pending |
| 10/30/2006 |
2006V-0448 |
Zokku/Laser Light Show |
Pending |
| 10/30/2006 |
2006V-0449 |
Electric Cowboy/Laser Light Show |
Pending |
| 10/31/2006 |
2006P-0445 |
Regulus Pharmaceutical Consulting, Inc./Determine if Mivacron
(mivacurium chloride injection) was withdrawn for safety or
efficacy reasons |
Interim Response 04/23/2007 |
| Top |
| November |
| 11/01/2006 |
2006P-0446 |
Taro Pharmaceuticals USA, Inc./ANDA for PHENERGAN Promethazine
Hydrochloride Suppositories USP, 12.5 mg and 25 mg |
Closed 07/30/2007 |
| 11/02/2006 |
2006P-0450 |
Pfizer Inc/Revoke approval of Allergan's supplemental NDA
#21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%)
and deny Alcon's supplemental NDA for Travatan (travopr
|
Pending |
| 11/13/2006 |
2006P-0461 |
B. Braum NMedical, Inc./To Permit the Filing of an ANDA Suitability
for Cefepime for Injection |
Pending |
| 11/13/2006 |
2006P-0462 |
Lachman Consultant Services, Inc./Determine whether Prevacid
NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg
capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by
Tap Pharm, has been voluntarily withdrawn or withhe |
Pending |
| 11/20/2006 |
2006P-0469 |
Strides Inc./Declare that a new drug application for Ibuprofen
Potassium 200 mg Phenylephine Hydrochloride 10 mg Capsules is
suitable for submission as an Abbreviated New Drug Application,
pursuant to 21 CFR 314.9 |
Pending |
| 11/20/2006 |
2006V-0470 |
Club MO Lasers/Laser Light Show Projector |
Pending |
| 11/20/2006 |
2006P-0471 |
Center for Science in the Public Interest/Issue standards
and regulations to help ensure the safe productions of fresh
fruits and vegetable |
Pending |
| 11/22/2006 |
2006V-0474 |
Palomar Medical Technologies, Inc./Variance for the Poalomar
Lux1540 handpiece |
Pending |
| 11/28/2006 |
2006P-0477 |
King & Spalding LLP/ANDA for potassium chloride oral solution
drug products in strengths of 10% and 5% |
Pending |
| 11/29/2006 |
2006P-0481 |
Actavis Totowa, LLC/ANDA Suitability for Oxycodone Hydrochloride
Capsules, 5 mg |
Pending |
| 11/29/2006 |
2006V-0482 |
Griffin Behm/Laser Light Show |
Pending |
| 11/29/2006 |
2006P-0484 |
M. McDole/Change the indication for Stimulant Medications
for the Treatment of Mental Diseases |
Denied 05/25/2007 |
| 11/29/2006 |
2006V-0485 |
N9NE Group dba Moon Bar/Projector for a Laser Light Show |
Approved 12/12/2006 |
| Top |
| December |
| 12/01/2006 |
2006P-0491 |
Kirkpatrick & Lockhart Nicholson Graham LLP/make a determination
that the withdrawal of the Reference Listed Drug (RLD), Psorcon
E (diflorasone diacetate oin tment) Emollient , Ointment, 0.05%,
was not for safety or effectiveness reasons. |
Interim Response 05/25/2007 |
| 12/04/2006 |
2006P-0496 |
Vintage Pharmaceuticals, LLC/Determine whether Sulfamethoxazole,
Trimethoprim, and Phenazopyride HCI, have been voluntarily withdrawn
or withheld for safety or efficacy reasons |
Interim Response 06/04/2007 |
| 12/05/2006 |
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.
|
Pending |
| 12/05/2006 |
2006P-0498 |
Center for Science in the Public Interest (CSPI)/Use of symbols
on the principal display panel that would communicate to consumers
the healthfulness of foods
|
Interim Response 06/01/2007 |
| 12/05/2006 |
2006V-0499 |
Des Monies Astronomical Society, Inc./Hand Held Portable Green
Laser Module |
Pending |
| 12/07/2006 |
2006P-0503 |
Lachman Consultant Services, Inc./ANDA Suitability for Propoxyphene
Napsylate and Acetaminophen |
Pending |
| 12/08/2006 |
2006P-0487 |
Cargill/Health Claim Petition: Isomaltulose and Dental Caries |
Interim Response 12/08/2006 |
| 12/08/2006 |
2006P-0505 |
Lachman Consultant Services, Inc/ANDA for Ursodial Capsules
USP, 100 mg 200 mg, and 400 mg |
Pending |
| 12/08/2006 |
2006V-0509 |
LFI International/Laser Light Show |
Interim Response 12/08/2006 |
| 12/11/2006 |
2006P-0506 |
Center for Science in the Public Interest/Request that the
FDA announce an Advance Notice of Proposed Rulemaking regarding
the use of symbols on the principal display panel that would
communicate to consumers the healthfulness of foods. |
Closed 12/19/2006 Duplicate of 2006P-0498 |
| 12/11/2006 |
2006P-0507 |
Sicor Pharmaceuticals, Inc./to permit an ANDA Suitability
for Methotrexate Injection |
Pending |
| 12/11/2006 |
2006P-0508 |
Charles E. Weber/Make 2 to 5 milligram pills of Naltrexone
to have over-the-counter status |
Interim Response 06/04/2007 |
| 12/11/2006 |
2006P-0511 |
Kleinfeld, Kaplan and Becker, LLP/Stay any action to grant
approval for Oxycodone Hydrochloride extended release tablets,
ANDA 77-822 |
Pending |
| 12/13/2006 |
2006P-0510 |
Lachman Consultant Services, Inc./ANDA Suitability for Propoxyphene
Hydrochloride 65 mg and Acetaminophen 325 mg Tablets |
Pending |
| 12/14/2006 |
2006P-0513 |
Caraco Pharmaceutical Laboratories, Ltd./Determine that the
Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg,
was voluntarily discontinued from sale in the US for reasons
other than safety or effectiveness
|
Pending |
| 12/18/2006 |
2006P-0518 |
Michael Patterson, Ph.D., BSEE/Stop all approvals of medical
devices and their components used for LASIK or place a moratorium
on their use |
Denied 07/20/2007 |
| 12/18/2006 |
2006P-0519 |
Michael Patterson, Ph.D., BSEE/Stop all approvals of medical
devices used for implantable lens implants including, but not
limited to Phakic IOLs (PIOLs) and Collamar Lenses or to place
a moratorium on their use |
Denied 07/20/2007 |
| 12/18/2006 |
2006P-0520 |
SICOR Pharmaceuticals, Inc./Determination for Methotrexate
Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA
11-719) |
Pending |
| 12/18/2006 |
2006V-0521 |
Mountain High Resort/Laser Light Show |
Pending |
| 12/18/2006 |
2006P-0522 |
Endo Pharmaceuticals Inc/Apply Bioequivalence Requirements
Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic
Drug Product using Lidoderm as its RLD |
Pending |
| 12/20/2006 |
2006P-0523 |
Sanofi-aventis US LLP/Require ANDA applicant for generic of
Eloxatin solution as reference drug to perform clinical testing |
Pending |
| 12/20/2006 |
2006P-0524 |
E. Tanghetti, MD/Withdrawal of Approval of and recall all
available stock of Ziana |
Pending |
| 12/22/2006 |
2006P-0534 |
King and Spalding, LLP/ANDA for Sterile Vancomycin Hydrochloride
USP, 750 mg |
Approved 08/22/2007 |
| 12/27/2006 |
2006P-0533 |
King & Spalding LLP/ANDA Suitability for Sterile Vancomycin
Hydrochloride USP, 750 mg |
Approved 08/22/2007 |
| 12/28/2006 |
2006P-0536 |
Vaccine For All LLC/Amend 21 C.F.R. 312. promotion and charging
for investigational drugs re: pandemic vaccine |
Pending |
