• Drug Safety Oversight Board Roster  (updated)
• Drug Safety Oversight Board Meeting, March 20, 2008 Public Summary
• Drug Shortage: Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
• BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written Request (updated)
• New and Generic Drug Approvals
  • Amitiza (lubiprostone) Capsules, Sucampo Pharma, New or Modified Indication 
  • Flomax (tamsulosin hydrochloride) Capsules, Boehringer Ingelheim Pharma, Labeling Revision
  • Imodium Advanced (loperamide hydrochloride and simethicone) Chewable Tablets, McNeil Consumer, Efficacy Supplement with Clinical Data to Support
  • Imodium Advanced (loperamide hydrochloride and simethicone) Tablets, McNeil Consumer, Efficacy Supplement with Clinical Data to Support
  • Losartan Potassium and Hydrochlorothiazide Tablets, Zydus Pharma, Tentative Approval
  • NuvaRing (etonogestrel and ethinyl estradiol) Vaginal Ring, Organon, Labeling Revision
  • Tenormin (atenolol) Tablets, AstraZeneca Pharma, Labeling Revision
  • Timolol Maleate Ophthalmic Solution, FDC Limited, Approval
• The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information.

May 1, 2008

• Guidance for Industry: Comprehensive List of Guidance Documents
• Guidance for Industry: New/Revised/Withdrawn List for 2008
• New and Generic Drug Approvals
  • Anastrozole Tablets, Zydus Pharma, Tentative Approval
  • Ciclopirox Topical Gel, Nycomed US, Inc., Tentative Approval
  • Ciprofloxacin Injection, Claris Lifesciences, Approval
  • Donepezil Hydrochloride Tablets, Teva Pharma, Approval
  • Escitalopram Oxalate Tablets, Zydus Pharma, Tentative Approval
  • Granisetron Hydrochloride Injection, Ebewe Parenta, Approval
  • Mepivacaine Hydrochloride Injection, Hospira Inc., Approval
  • Metoprolol Tartrate Injection, Hospira Inc., Approval
  • Omeprazole Delayed-Release Capsules, Lek Pharm, Tentative Approval
  • Optiray (Ioversol) Injection, Mallinckrodt, Labeling Revision
  • Penicillin V Potassium Tablets, Aurobindo Pharma, Approval
  • Sodium Chloride 0.9% in Plastic Container Injection, Mallinckrodt, Labeling Revision
  • Trandolapril Tablets, Mylan Pharma, Approval
• Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
• Prescription Drug User Fee Act (PDUFA) Billable Products  (updated)

April 30, 2008

• Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (updated)
• Drugs@FDA Downloadable Data Files (updated)
• FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over.
• Postmarketing Study Commitments (updated)

April 29, 2008

• Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP), a drug used to treat heart failure and abnormal heart rhythms
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Efavirenz Tablets, Matrix Labs, Tentative Approval
  • Lamivudine and Zidovudine Tablets, Hetero Drugs, Tentative Approval
  • Optiray (Ioversol) Injection, Mallinckrodt, Labeling Revision
  • Thioridazine Hydrochloride Tablets, Mylan Pharma, Expiration Date Change
  • Zidovudine Tablets, Hetero Drugs, Approval

April 28, 2008

• Drug Master Files (updated)
• Drug Shortage: Resolved; Lymphazurin 1% injection (isosulfan blue)
• New and Generic Drug Approvals
  • Anastrazole Tablets, Watson Labs, Tentative Approval
  • Aplenzin (Bupropion Hydrobromide) Extended-release Tablets, Biovail Labs, Approval
  • Children's Cetirizine Hydrochloride Allergy Syrup, Ranbaxy Labs, Approval
  • Children's Cetirizine Hydrochloride Hives Relief Syrup, Ranbaxy Labs, Approval
  • Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Capsules, Watson Labs, Labeling Revision
  • Maxitrol (neomycin sulfate, polymyxin B sulfate and dexamethasone) Ophthalmic Suspension, Falcon Pharma, Labeling Revision
  • Moxifloxacin Hydrochloride Tablets, Dr. Reddy’s Labs, Tentative Approval 
  • Nicotine Polacrilex Gum (2 mg), Perrigo R & D, Approval
  • Nicotine Polacrilex Gum (4 mg), Perrigo R & D, Approval
  • Phentermine Hydrochloride Capsules, KVK-Tech, Approval
  • Primidone Tablets, Amneal Pharma, Approval
  • Promethazine Hydrochloride Injection, Hikma Farmaceutica, Approval
  • Relistor (methylnaltrexone bromide) Subcutaneous Injection, Progenics Pharma, Approval
  • Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
  • Singulair (montelukast sodium) Tablets, Merck & Co., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck & Co., Labeling Revision

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May 1, 2008 Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.   April 30, 2008 Federal Register: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop. Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing.   April 29, 2008 Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Brief Summary   April 28, 2008 Federal Register: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period.

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