• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Office of Generic Drugs: April First-Time Generic Drug Approvals

May 8, 2008

• Letters
  • Notice of Violation Letter: Fosrenol (lanthanum carbonate)
  • Warning Letter: Trileptal (oxcarbazepine)
• Paragraph IV Patent Certifications (updated 5/7/2008)

May 7, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
  • Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
  • Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
  • Argatroban Injection, Encysive Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support
  • Brevital Sodium (methohexital sodium) Injection, JHP Pharmaceuticals, LLC, Labeling Revision
  • Bumetanide Injection, Baxter Healthcare Corp., Approval
  • Cardiolite (Technetium Tc99m Sestamibi Kit) Injection, Bristol Myers Squibb, Patient Population Altered
  • Humalog Mix 50/50 (insulin lispro protamine [rDNA origin] and insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
  • Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck & Co., Inc., Manufacturing Change or Addition
  • Levaquin (levofloxacin) Tablets, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Levaquin (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Ropinirole Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Approval
  • Ropinirole Hydrochloride Tablets, Teva Pharmaceuticals, Approval
  • Ropinirole Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
  • Ropinirole Hydrochloride Tablets, Par Pharmaceutical, Inc., Approval
  • Sensipar (cinacalcet hydrochloride) Tablets, Amgen, Inc., Labeling Revision
  • Vancocin Hydrochloride in Plastic Container (vancomycin hydrochloride) Injection, Baxter Healthcare Corp., Labeling Revision

May 6, 2008

• CDER Manual of Policies and Procedures (MaPPs) 4520.2R Providing General Consumer Information on New Molecular Entities on CDER’s Web Site
• FDA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07), June 4-5, Washington, DC. Meeting information and registration
• New and Generic Drug Approvals
  • Azelastine Hydrochloride Nasal Spray, Apotex Inc., Tentative Approval
  • Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals, Package Change
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Lexiva (fosamprenavir calcium) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • Pravastatin Sodium Tablets, Zydus Pharmaceuticals, Approval
  • Zolpidem Tartrate Tablets, Hikma Pharmaceuticals, Approval
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, Attachment A   Attachment B
• Pubic Workshop: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7, 2008, Silver Spring, MD. Federal Register Notice

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May 8, 2008 Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides PMA Final Decisions for April 2008   May 7, 2008 Summary Information for: Thoratec HeartMate II Left Ventricular Assist System (LVAS)   May 6, 2008 Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization Consumer Information on: Thoratec HeartMate II LVAS - P060040   May 5, 2008 510(k) Final Decisions - April 2008

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