• New and Generic Drug Approvals
  • Minocycline Hydrochloride Capsules, Aurobindo Pharma, Approval
  • Monurol (fosfomycin tromethamine) Zambon, Labeling Revision
  • Paclitaxel Injection, PLIVA, Approval
  • Septra (sulfamethoxazole; trimethoprim) Tablets, and Septra DS (sulfamethoxazole; trimethoprim) Tablets, Monarch Pharms, Labeling Revision
  • Septra (sulfamethoxazole; trimethoprim) Suspension, Monarch Pharms, Labeling Revision
  • Septra (sulfamethoxazole; trimethoprim) I.V., Monarch Pharms, Labeling Revision
  • Tobramycin (tobramycin sulfate) Injection, Akorn-Strides, Approval
  • Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension, UCB Inc., Labeling Revision
  • Urex (methenamine hippurate) Oral Tablets, Vatring Pharms, Labeling Revision
  • Urso Forte (ursodiol, USP) Tablets, Axcan Scandipharm, Package Change
  • VFEND (voriconazole) Tablets, Pfizer Inc., Labeling Revision
  • VFEND (voriconazole) I.V. for Injection, Pfizer Inc., Labeling Revision
  • VFEND (voriconazole) for Oral Suspension, Pfizer Inc., Labeling Revision
• Amgen and FDA notify healthcare professionals of changes to the Boxed Warnings/Warnings for increased mortality and/or tumor progression section of the Aranesp and Epogen/Procrit labeling. MedWatch Information
• Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book
• Dissolution Methods Database (updated)
• Drug Approval Reports
  • NDA and BLA Approvals (updated)
  • NME Drug and New Biologic Approvals (updated)
  • Priority NDA and BLA Approvals (updated)
• FDA and Tibotec Therapeutics notify healthcare professionals of changes to the Warnings section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. MedWatch Information

March 12, 2008

• New and Generic Drug Approvals
  • Clobetasol Propionate Foam, Perrigo, Approval
  • Levoleucovorin Injection, Spectrum Pharms, Approval
  • Prozac (fluoxetine HCl) Capsules, Eli Lilly and Co., Labeling Revision
  • Prozac (fluoxetine HCl) Oral Solution, Eli Lilly and Co., Labeling Revision
  • Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly and Co., Labeling Revision
  • Rosiglitazone Maleate Tablets, Roxane Labs, Tentative Approval
• BPCA/Pediatric Exclusivity Statistics:
  • Written Requests Issued (updated)
  • Written Requests Statistics (updated)
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims [PDF] or [HTML]
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Office of Generic Drugs: February First-Time Generic Drug Approvals
• Paragraph IV Patent Certifications (updated)

March 11, 2008

• FDA updates screening method for heparin: Impurity Evaluation of Heparin Sodium by ¹H-NMR Spectroscopy
• FDA issues an Information for Healthcare Professionals sheet and Public Health Advisory for Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product. Drug Information
• FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008. Meeting Information

March 10, 2008

• New and Generic Drug Approvals
  • Abilify (aripiprazole) Tablets, Otsuka, Labeling Revision
  • Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Otsuka, Labeling Revision
  • Abilify (aripiprazole) Oral Solution, Otsuka, Labeling Revision
  • Abilify (aripiprazole) Injection, Otsuka, Labeling Revision
  • Nabumetone Tablets, InvaGen Pharma, Approval
  • Ponstel (mefenamic acid) Capsules, Sciele Pharma, Labeling Revision
  • Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Assoc., Approval
  • Prezista (darunavir ethanolate) Tablets, Tibotec Inc., Labeling Revision
  • Singulair (montelukast sodium) Tablets, Merck and Co., Labeling Revision
  • Singulair (montelukast sodium) Chewable Tablets, Merck and Co., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck and Co., Labeling Revision

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March 11, 2008 FDA Reminds Glucose Meter Users to Only Use Strips Recommended For Their Meter   March 10, 2008 Class II Recall: Chattem, Inc. Icy Hot Heat Therapy Products

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