• Acronyms and Abbreviations Database Download File
• Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book
• New and Generic Drug Approvals
  • Benztropine Mesylate Tablets, Actavis, Approval
  • Emsam Patches (selegiline) Transdermal System, Somerset Pharma, Labeling Revision
  • Granisetron Hydrochloride Tablets, Orchid Healthcare, Approval
  • Halcion (triazolam) Tablets, Pharmacia & Upjohn, Labeling Revision
  • Letairis (ambrisentan) Tablets, Gilead Sciences, Labeling Revision
  • Primidone Tablets, Impax Labs, Approval
  • Promethazine Hydrochloride Tablets, Impax Labs, Approval
  • Ramipril Capsules, Dr. Reddy’s Labs, Tentative Approval 
  • Vinorelbine Injection, EBEWE Pharma, Approval
  • VIRACEPT (nelfinavir mesylate) Oral Powder, Agouron Pharma, Labeling Revision
  • VIRACEPT (nelfinavir mesylate 250mg) Tablets, Agouron Pharma, Labeling Revision
  • VIRACEPT (nelfinavir mesylate 625mg) Tablets, Agouron Pharma, Labeling Revision
  • Zidovudine Tablets, Mylan Pharma, Tentative Approval 
• Pediatric Exclusivity Granted (updated)
• Pediatric Exclusivity Determinations Made under Section 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) (updated)
• PriCara and Sandoz Inc. recall all lots of 25 mcg/hr Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches sold in the United States.
• Warning Letters
  • BMIS Inspection, Replidyne, Inc.
  • BMIS Inspection, Surendra Chaganti, M.D.

February 14, 2008

• Guidance for Industry: Safety Testing of Drug Metabolites [PDF] or [HTML]
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
• New and Generic Drug Approvals
  • Abreva (docosanol) Cream, GlaxoSmithKline, Manufacturing Change or Addition
  • Azithromycin Tablets, Wockhardt, Approval
  • Bicalutamide Tablets, Sandoz Inc., Tentative Approval
  • Divalproex Sodium Delayed-release Tablets, Sun Pharma, Tentative Approval
  • Doryx (doxycycline hyclate) Delayed-Release Capsules, Warner Chilcott, Labeling Revision
  • Duragesic (fentanyl) Transdermal System, Alza Corp., Labeling Revision
  • Effexor XR (venlafaxine HCl) Extended Release Capsules, Wyeth Pharma, Labeling Revision
  • Effexor (venlafaxine HCl) Immediate Release, Wyeth Pharma, Labeling Revision
  • FENTORA (fentanyl buccal) Tablet, Cephalon Inc., Labeling Revision
  • Finasteride Tablets, Actavis, Tentative Approval
  • Hydrochlorothiazide Capsules, Cadista Pharma, Approval
  • Hydrocodone Bitartrate and Homatropine Methylbromide Syrup, Hi-Tech Pharmacal, Approval
  • Levalbuterol Hydrochloride Inhalation Solution, Dey, Tentative Approval
  • Norflex (Orphenadrine Citrate) Injection, Graceway Pharma, Labeling Revision
  • Pravastatin Sodium Tablets, Lek Pharma, Approval
  • Propoxyphene Napsylate and Acetaminophen Tablets, Concord Labs, Approval
  • Unithroid (levothyroxine sodium) Tablets, Jerome Stevens Pharma, Formulation Revision
  • VESIcare (solifenacin succinate) Tablets, Astellas Pharma, Labeling Revision
  • Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision
  • Zetia (Ezetimibe) Tablets, Schering Corp., Labeling Revision

February 13, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Duragesic (fentanyl transdermal system) Medication Guide
• New addresses and phone numbers for PDUFA correspondence

February 12, 2008

• New and Generic Drug Approvals
  • Diclofenac Sodium Ophthalmic Solution, Alcon Research, Approval
  • Ditropan (oxybutynin chloride) Tablets, Alza, Labeling Revision
  • Ditropan (oxybutynin chloride) Syrup, Alza, Labeling Revision
  • Ditropan XL (oxybutynin chloride) Extended Release Tablets, Alza, Labeling Revision
  • Divalproex Sodium Delayed-Release Tablets, Sandoz Inc., Tentative Approval
  • Divalproex Sodium Delayed-Release Tablets, Nu-Pharm, Inc., Tentative Approval
  • Famotidine, Calcium Carbonate, and Magnesium Hydroxide, Chewable Tablets, Perrigo R&D Co., Approval
  • Fluconazole Tablets, Teva Pharma, Control Supplement
  • Tagamet HB 200 (cimetidine) Tablets, GlaxoSmithKline, Labeling Revision
  • Tramadol Hydrochloride Tablets, Watson Labs, Control Supplement
  • Vibramycin (doxycycline monohydrate) Oral Suspension, Pfizer Inc., Labeling Revision
  • Vibramycin (doxycycline hyclate) Capsules, Pfizer Inc., Labeling Revision
  • Vibramycin Calcium (doxycycline hyclate) Syrup, Pfizer Inc., Labeling Revision
  • Vibramycin (doxycycline hyclate) Film-Coated Tablets, Pfizer Inc., Labeling Revision
• BPCA/Pediatric Exclusivity Statistics:
  • Written Requests Issued (updated)
  • Written Requests Statistics (updated)
• Drug Approval Reports
  • NDA and BLA Approvals (updated)
  • NME Drug and New Biologic Approvals (updated)
  • Priority NDA and BLA Approvals (updated)
  • Efficacy Supplement Approvals (updated)
  • New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)

February 11, 2008

• FDA announces that Baxter Healthcare Corp. has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension.
• National Drug Code Directory Download (updated)
• National Drug Code Directory Search (updated)
• Office of Generic Drugs: January First-Time Generic Drug Approvals
• Paragraph IV Patent Certifications (updated)

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February 15, 2008 Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses; Availability. Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions   February 14, 2008 Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses    February 12, 2008 Consumer Information on: Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems - P060033  Summary Information for: Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems   February 11, 2008 Consumer Information on: xTAG Respiratory Viral Panel (RVP) - K063765

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