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Center for Drug Evaluation &
Research (CDER) News

• CDER Organization Charts [HTML] [PDF] (updated)
• Drug Shortages: Current Drug Shortage: Mitomycin for injection (updated)
• New and Generic Drug Approvals
  • Amlodipine Besylate Tablets, Alkem Laboratories Ltd., Approval
  • Ancoban (flucytosine) Capsules, Valeant Pharmaceuticals International, Labeling Revision
  • Cancidas (caspofungin acetate) Injection, Merck Research Laboratories, Labeling Revision
  • CeeNu (lomustine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
  • Children's Motrin Cold (ibuprofen and pseudoephedrine hydrochloride) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision
  • Children's Motrin (ibuprofen) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision
  • Dilaudid-HP (hydromorphone hydrochloride) Injection, Purdue Pharma L.P., New Dosage Regimen
  • Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Approval
  • Granisetron Hydrochloride Injection, Sandoz Canada Inc., Approval
  • Levetiracetam Tablets, Zydus Pharmaceuticals USA Inc., Approval
  • Mivacurium Chloride Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval
  • Orap (pimozide) Tablets, Teva Pharmaceuticals, USA, Labeling Revision
  • Risperidone Orally Disintegrating Tablets, Zydus Pharmaceuticals USA Inc., Approval
  • Risperidone Orally Disintegrating Tablets, Kali Laboratories, Inc., Approval
  • Stromectol (ivermectin) Tablets, Merck & Co., Inc., Labeling Revision
  • Tenofovir Disoproxil Fumarate Tablets, Cipla Ltd., Tentative Approval
  • Treanda (bendamustine hydrochloride) I.V. Powder, Cephalon, Inc., Control Supplement
  • Tyzeka (telbivudine) Oral Solution, Novartis Pharmaceuticals Corp., Approval 
  • Vancomycin Hydrochloride Injection, Hospira Inc., Approval
• Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide
• The Dear Colleague Letter, in anticipation of FY 2010 Invoices, was mailed Tuesday, May 5, 2009

May 7, 2009

• Drug Shortages: Current Drug Shortage: Metoprolol succinate extended release tablets (updated)
• Drug Shortages: Current Drug Shortage: Mitomycin for injection (updated)
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry:
  • Comprehensive List of Guidance Documents
  • New Revised/Withdrawn List for 2009
• New and Generic Drug Approvals
  • Arimidex (anastrozole) Tablets, AstraZeneca, Labeling Revision
  • Axert (almotriptan malate) Tablets, Johnson & Johnson Pharmaceutical Research & Development, Labeling Revision
  • Azelastine Hydrochloride Nasal Spray, Apotex Inc., Approval
  • Butorphanol Tartrate Injection, Hikma Famaceutica, Approval
  • CETRAXAL (ciprofloxacin) Otic Solution, Laboratorios SALVAT, S.A., Approval
  • Children’s Motrin (ibuprofen) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision

May 6, 2009

• BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
• Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic

May 5, 2009

• FDA issues an Update about Suicidal Behavior and Ideation and Antiepileptic Drugs
• New and Generic Drug Approvals
  • Adenosine Injection, Wockhardt, Ltd., Tentative Approval
  • Adenosine Injection, Luitpold Pharmaceuticals, Inc., Approval
  • Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision
  • Junior Strength Motrin (ibuprofen) Chewable Tablets, McNeil Consumer Healthcare, Labeling Revision
  • Levaquin (levofloxacin) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Levaquin (levofloxacin) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Levaquin (levofloxacin) Oral Solution, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Lorazepam Oral Concentrate, Paddock Laboratories, Inc., Approval
  • Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision
  • Orapred ODT (prednisolone sodium phosphate) Orally Disintegrating Tablets, BioMarin Pharmaceutical, Inc., Manufacturing Change or Addition
  • Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed, Inc., Labeling Revision
  • Technetium Tc 99m Sestamibi Injection, Cardinal Health 414, LLC, Approval

May 4, 2009

• Division of Drug Marketing, Advertising, and Communications (DDMAC): Presentations (updated)
• Paragraph IV Patent Certifications (updated)

CDER Drug Links

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Hot Topics

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