Dockets

Require Bioequivalence Studies for Generic or Follow-on Formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml) (New 10/18/06)

Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension (Updated 3/7/07)

Revise the labeling requirements for eggs sold in the United States (New 8/22/07)

Refrain from Approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat (New 6/4/07)

Food Allergen Labeling Petition (FALP): Soy Lecithin When Used as Processing Aids (New 10/10/06)

To Urge the FDA's Prompt Action to Cancel the GRAS Designation for Diacetyl Until Testing is Complete and the Results are Independently Evaluated (Updated 8/27/07)

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 (Updated 3/8/07)

Revoke FDA's Prior Approval of Vagus Nerve Stimulation (VNS) for Mangement of Treatment-resistant Depression (TRD) (New 10/13/06)

ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05% (Updated 10/13/06)

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/or Subject to Tampering (New 10/10/06)

Reformulation of Central Nervous System (CNS) Stimulant Drugs (New 3/8/07)

Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device (Updated 7/24/07)

General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device (Updated 10/22/07)

Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025% (New 10/03/06)

Determine that the Discontinued Formulation of Carbocaine Injection, 3% Supplied in 1.8 mL Cartridge was not Discontinued for Safety and Efficacy Reasons (Updated 3/7/07)

Amend the Vancomycin HCl Package Insert to Reflect Modifications of the Antimicrobial Susceptibility Interpretive Criteria to Better Recognize Emerging Resistance Resulting in Compromised Patient Outcomes (Updated 10/18/06)

Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays (Updated 8/6/07)

Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. Associated with Menopause (New 9/19/06)

Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (New 3/13/07)

Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data (New 1/18/07)

Reclassification Petition fo Bone Heterografts (Updated 11/1/07)

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research (Updated 11/13/06)

Regarding Review of Policies and Practices of DDMAC and OCBQ to Ensure Compliance with First Amendment and Statutory Mandate (New 8/17/06)

Request for Advisory Opinion Concerning Orange Book Listing of Patents (New 8/17/06)

Health Claim: Phytosterols and Reduced Risk of Coronary Heart Disease (Updated 9/19/06)

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 (New 8/25/06)

Compel the Agency to Follow Requirements of the Drug Listing Act of 1972 (New 8/25/06)

ANDA for ELOXATIN (oxaliplatin for injection) lLyophilized Powder for Infusion, 50 mg and 100 mg Vials (New 8/25/06)

To amend 21CFR 201.17 Regarding Expiration Dates (New 8/24/06)

Publish Specific Requirements for Applications Seeking Approval to Market Ttherapeutically Equivalent Versions of Insulin and Human Growth Hormone (Updated 3 /20/07 )

Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg (Updated 10/11/06)

Permit the Filing of an ANDA Suitability for Sodium Chloride Injection (New 8/22/06)

ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg (New 8/22/06)

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 (New 8/22/06)

To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection) (New 8/14/06)

Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons (New 8/14/06)

Risk Management Program for Fentanyl Products (New 8/7/06)

Permit an ANDA Suitability for Alprazolam (New 8/11/06)

Determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been Voluntarily Withdrawn from Sale for Safety or Efficacy Reasons (New 8/11/06)

Food Allergen Labeling (FALN): Lyophilized Probiotic Cultures (Updated 8/11/06)

Determine Whether Phoslo (calcium acetate) Capsules eq169 mg calcium have been Voluntarily Withdrawn from Sale for Safety or Effcacy Reasons (New 8/9/06)

Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale (New 8/9/06)

Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319 (New 10/27/06)

Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet (New 8/1/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products (New 8/22/06)

Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006 (New 8/1/06)

Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products (Updated 8/8/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act (New 8/9/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements (New 8/9/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile (Updated 1/12/07)

ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL Volumes (Updated 9/19/06)

ANDA Suitability for 0.9% Sodium Chloride Injection (New 7/31/06)

Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSl (Updated 3/20/07)

Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504 (New 2/23/07)

Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784 (New 07/25/06)

Food and Drug Administration to Make a Determination that the Discontinued Formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not Discontinued for Safety and Efficacy Reasons (Updated 4/19/07)

Label Change or Removal from the Market of the Psychotropic Drug Depakote (Updated 10/11/06)

Refrain from Approving all Abbreviated Applications for Generic Enrofloxacin that Purport to Copy Bayer's Baytril 100 Injectable Solution (Updated 12/20/06)

Manufactured Food Regulatory Program Standards (Updated 9/10/07)

Qualified Health Claim (QHC) : Corn Oil and corn Oil Containing Foods and Heart Disease (Updated 7/27/06)

Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules (Updated 1/22/07)

Appeal District Court Civil Action No. 05-1838 (RWR) and Deny the Citzen Petitions of Ivax and Ranbaxy (Updated 7/28/06)

Food Allergen Labeling Petition (FALP): Culture Media with Enzyme-Treated Soy Solids (New 6/20/06)

Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredient (New 8/22/06)

Abbrevation New Drug Application Suitability for Lidocaine Hydrochloride (New 7/14/06)

Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy Guide (Updated 1/19/07)

Take Appropriate Remedial Action Against the Apparent Misbranding of Generic Azithromycin Marketed by Pliva, Inc. (Updated 7/28/06)

Switch Plan B and Equivalent EC Drugs from Precription-only to OTC Status Without Age Restrictions, Exempt from Prescription-dispensing Requirement any new Drug Eligible for Filing an ANDA Because of its Equivalence to Plan B (Updated 10/23/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices (Updated 6/21/06)

To Permit an Abbrevation New Drug Application Triamcinolone Diacetate Suspension (New 7/07/06)

Amend Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles sSpecifically (Updated 3/8/07)

Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml (Updated 8/24/06)

Permit the Filing of an ANDA for Loratadine Soft Gelatin Capsules 10 mg (Updated 6/21/06)

ANDA Suitability for Cetirizine Hydrochloride Soft Gelatin Capsules 5 mg and 10 mg (Updated 7/6/06)

Require Vitamin D be Added to Cereal-grain Products (Updated 8/22/06)

Cefotan (cefotetan injection), Equivalent 1 g base/vial and 2 g base/vial, Manufactured by AstraZeneca has been Voluntarily Withdrawn from Sale for Safety and Efficacy Reasons (New 6/30/06)

ANDA for Lithium Carbonate Tablets, 300 mg (NDA 016834) (Updated 8/30/06)

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 Abbreviated New Drug Applications Seeking Approval to Market Zosyn Formulation (Updated 8/11/06)

Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (Updated 10/03/06)

Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availabilit (Updated 6/21/06)

Withdraw New Drug Application NDA 21-179 FOR Renagel Tablets (Severlamer Hydrochloride) 400 AND 800 MG (Updated 11/21/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses (New 8/9/06)

Product Stability Data: Notice of Pilot Project (New 8/4/06)

Immediately Ban Fluoroquinolone Antibiotic Gatifloxacin in Humans (Updated 11/21/06)

ANDA Suitability for Methotrexate (Updated 6/30/06)

FDA to Determine that any Drug is Therapeutically Equivalent or AB-rated to BiDil (Isosorbide Dinitrate and Hydralazine Hydrochloride) (New 6/30/06)

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 (Updated 8/11/06)

Food Labeling: Reference Daily Intakes & Daily Reference Values (New 2/13/08)

ANDA Suitability for Oxycodone and Acetaminophen Drug Product in an Orally Disintigrating Form (New 6/28/06)

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 Misbranded as Defined by 21 U.S.C. 352(a); and to Impose Appropriate Remedies Against, and to Require Corrective Actions by International Tan Makers, Inc. (New 6/27/06)

Request ANDA Suitability of Dichlorphenamide Tablets USP, 50 mg (New 6/27/06)

Revoke Regulations that Provided for the Inclusion and Addition of Sucralose as a Non-nutritive Sweetener in Food (New 6/27/06)

Remove from the Market, the Prescription Version of Xenical (Orlistat, Roche Pharmaceuticals) (Updated 02/08/07)

Stay the Current Approvable Letter with Conditions of Any and All Premarket Applications for Silicone Gel-filled Breast Implants (Updated 8/8/06)

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 (Updated 07/28/06)

Amend Reg. for Prescription Drug Advertising to Establish Separate Criteria for Practitioner-Directed & Consumer-Directed Advertising and Establish Advisory Committee (Updated 8/03/06)

ANDA Suitability for Gemcitabine (New 6/19/06)

Delalutin Hydroxyprogesterone Caproate) Injection was not Withdrawn for Safety or Effectiveness Reasons and Therefore Suitable for ANDA (Updated 7/18/06)

Laser Light Show (New 6/9/06)

Laser Light Show (New 6/9/06)

To withhold Approval of any ANDA for a Generic Version of Acitretin Capsules (New 5/1/06)

Nutrient Content Claims: EPA and DHA Omega-3 Fatty Acids (Updated 6/22/06)

Issue Guidance to Industry Outlining Procedures and Standards for Initiating an "Expanded Access Program" for Unapproved Drugs (Updated 9/19/06)

ANDA suitability for Epirubicin Hydrochloride (Updated 5/22/06)

Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie" (Updated 8/8/06)

Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons (New 4/20/06)

Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules (Updated 4/2/07)

Request all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products (Updated 8/23/07)

ANDA Suitability for Cetirizine Hydrochloride Orally Disintegrating Tablets, 5 mg and 10 mg (New 4/17/06)

Enforce ban on carbon monoxide in the packaging of fresh tuna and fresh tuna that is subsequently frozen (New 4/17/06)

Food Allergen Labeling Notification (FLN): Anyhydrous Lactitol and Lactitol Monohydrate (New 3/20/06)

Laser Light Show (New 5/15/06)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Reagents for Detection of Specific Novel Influenza A Viruses (New 5/31/06)

ANDA Suitability for Omeprazole Tablets, 20 mg (proposed formulation) (New 4/17/06)

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% (Updated 10/18/06)

Projector for a Laser Light Show (New 5/15/06)

Laser Display Device (New 5/15/06)

New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition (New 5/10/06)

Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25) (New 6/13/06)

Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format (New 6/13/06)

Take Appropriate Remedial Action Relating to an Apparent Safety Issue rRegarding Bellatal ER (New 10/13/06)

Petition for Review of Codex Standard for Honey Under 21 CFR 130.6 (Updated 10/13/06)

Medical Devices; Immunology and Microbiology Devices; Classification of Reagents for Detection of Specific Novel Influenza A Viruses (New 5/22/06)

Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses (New 5/22/06)

Define the term natural before a natural claim can be made on foods and beverages regulated by the FDA (Updated 3/22/07)

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. (Updated 8/22/06)

Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded (New 9/19/06)

Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease (Updated 10/17/06)

Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing product (Updated 10/06/06)

Stay Approval of all Supplements to Biologics Licenses Issued to Genentech (BLA# 103705 ) and Biogen (BLA# 103737) for Rituxan (Rituximab) (Updated 10/03/06)

Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (Updated 7/17/06)

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) (New 9/19/06)

To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements under section 510(m)(2) (Updated 2/23/07)

Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines (Updated 5/17/06)

Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203 (Updated 7/18/06)

Refrain from Lifting the Administrative Stay for Amlodipine Maleate Tablets (NDA 21-435) Until After September 25, 2007 (New 9/1/06)

ANDA for Prednisolone Sodium Phosphate, USP, Oral Solution, 10 mg Prednisolone Base/5mL (New 6/19/06)

Misbranding of Generic Azithromycin Products Marketed by Teva Pharmaceuticals USA and Sandoz Inc.(Updated 8/25/06)

Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease (Updated 6/30/06)

Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been Voluntarily Withdrawn for Safety or Effectiveness Reasons (Updated 8/1/06)

Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (New 02/13/2007)

Emerging Clostridial Disease; Public Workshop (Updated 06/21/06)

Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability (New 10/18/06)

Expanded Access to Investigational Drugs for Treatment Use (Updated 7/10/07)

ANADA for Unibute Granules 200 mg Phenylbutazone per g of Granules Instant of Paste (Updated 6/22/06)

Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been Voluntarily Withdrawn for Safety or Effectiveness Reasons (New 08/22/06)

Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation (New 10/02/06)

Reduce the Public Health Risks Associated with the Use of Drugs Manufactured or Processed at Foreign Facilities (New 8/14/06)

Refrain from Approval any ANDA for Celestone Soluspan (Updated 7/28/06)

Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767 (New 2/13/06)

Genetic Toxicology Testing: the Ames Assay, Mouse Lymphoma Assay and the Micronucleus Assay (Updated 45/24/07)

Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990 (New 2/13/06)

Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,24 (New 2/13/06)

Genetic Toxicology Testing: the Ames Assay, Mouse Lymphoma Assay and the Micronucleus Assay (New 2/14/06)

To Issue a Regulation that would Efficaciously Inform the General Public about the Quantitaive Caffeine Content of the Foods they Consume (New 2/13/06)

Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device (New 6/15/06)

Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents (Updated 6/20/06)

Food Allergen Labeling Notification for Purity Foods Vita Spelt (Updated 6/20/06)

Projector for a Laser Light Show (New 2/13/06)

Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers (New 7/3/06)

Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536 (New 2/13/06)

Oxycodone Hydrochloride and Acetaminophen Oral Solution, 10 mg / 300 mg/5 mL. (Updated 5/10/06)

Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819 (New 2/13/06)

Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876 (New 2/13/06)

Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269 (New 2/13/06)

Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179 (New 2/13/06)

FDA to declare that Methocarbamol Tablets USP, 1000 mg is suitable for submission as an ANDA (New 2/13/06)

Date of Approval for Lunesta (Eszopiclone) Tablets (Updated 8/1/06)