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Center for Drug Evaluation &
Research (CDER) News

• FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml
• Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announces that it has begun a voluntary, phased withdrawal of the product from the U.S. market.
• Bioresearch Monitoring Information System (BMIS) (updated)
• Dissolution Methods Database (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Shortages: Current Drug Shortage: Acyclovir Injection (updated)
• National Drug Code Directory (updated)
• New and Generic Drug Approvals
  • CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
  • CIPRO (ciprofloxacin hydrochloride) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
  • Claritin (loratadine) Capsules, Schering-Plough, Labeling Revision
  • Fomepizole Injection, GeneraMedix, Inc., Approval
  • Ibandronate Sodium Injection, Teva Parenteral Medicines, Inc., Tentative Approval
  • KALETRA (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
  • KALETRA (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
  • LUNESTA (eszopiclone) Tablets, Sepracor, Inc., Package Change
  • Minipress (prazosin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
  • Mucinex DM (guaifenesin and dextromethorphan) Extended-Release Tablets, Reckitt Benckiser, Package Change

April 8, 2009

• Drug Shortages: Current Drug Shortage: Morphine Sulfate Oral Solution
• Drugs@FDA Downloadable Data Files (updated)
• Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop April 18, 2009, Washington, D.C.
• Office of Generic Drugs
  • March First-Time Generic Drug Approvals

April 7, 2009

• Drug Shortages: Current Drug Shortage: Azactam 1 gram and 2 gram (Aztreonam for Injection) (updated)
• Drug Shortages: Current Drug Shortage: Cisplatin Injection 1mg/m (updated)
• Drug Shortages: Resolved Drug Shortage: Amikacin Sulfate Injection
• Guidance for Industry:
  • Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions
    • Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter [PDF]
    • Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [PDF]
    • Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [PDF]
  • Q10 Pharmaceutical Quality System [PDF]
• New and Generic Drug Approvals
  • Arava (leflunomide) Tablets, Sanofi-aventis, Labeling Revision
  • Hydrochlorothiazide Capsules, Ipca Laboratories Ltd., Approval
  • Levetiracetam Oral Solution, Silarx Pharmaceuticals, Inc., Approval
  • Mucinex (guaifenesin) Extended-Release Tablets, Reckitt Benckiser, Control Supplement
  • Omeprazole Delayed-Release Tablets, Lachman Consultant Services, Inc., Labeling Revision
  • PREVPAC (lansoprazole and amoxicillin and clarithromycin) Capsules, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Soma Compound (aspirin and carisoprodol) Meda Pharmaceuticals, Inc., Labeling Revision

April 6, 2009

• Adverse Event Reporting System (AERS) Statistics (updated)
• Manual of Policies and Procedures (MaPP): 5210.3R Productivity Documentation in the Division of Bioequivalence
• New and Generic Drug Approvals
  • Buphenyl (sodium phenylbutyrate) Tablets, Medicis Pharmaceutical Corp., Labeling Revision
  • Buphenyl (sodium phenylbutyrate) Oral Powder, Medicis Pharmaceutical Corp., Labeling Revision
  • Carbamazepine Extended-Release Tablets, Taro Pharmaceutical Industries Ltd., Approval
  • Enlon Plus (edrophonium chloride and atropine sulfate) Injection, Bioniche Phara USA, LLC, Manufacturing Change or Addition
  • Famciclovir Tablets, Roxane Laboratories, Inc., Tentative Approval
  • Heparin Sodium Injection, APP Pharmaceuticals, LLC, Labeling Revision
  • Indocin (indomethacin) Oral Suspension, IROKO Pharmaceuticals, LLC, Labeling Revision
  • Methotrexate Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval
  • Sutent (sunitinib malate) Capsules, Pfizer Inc., Control Supplement
• Prescription Drug User Fee Act (PDUFA) Billable Products  (updated 4/2/2009)

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