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Center for Drug Evaluation &
Research (CDER) News

• Drug Master files (updated)
• Guidance for Industry:Guidances CDER is Planning to Develop During Calendar Year 2009
• New and Generic Drug Approvals
  • Amaryl (glimepiride) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision
  • Amicar (aminocaproic acid) Oral Solution, Xanodyne Pharmaceuticals, Inc., Labeling Revision
  • COMBIVIR (lamivudine and zidovudine) Tablets, GlaxoSmithKline, Patient Population Altered
  • Comtan (entacapone) Tablets, Orion Corp., Labeling Revision
  • EMEND (aprepitant) Capsules, Merck & Co., Inc., Labeling Revision
  • EMEND (fosaprepitant dimeglumine) Injection, Merck & Co., Inc., Labeling Revision
  • Lithium Carbonate Capsules, Glenmark Generics Inc., Approval
  • Minocycline Hydrochloride Extended-release Tablets, Impax Laboratories, Inc., Approval
  • Stalevo (levodopa andcarbidopa and entacapone) Tablets, Orion Corp., Labeling Revision
  • Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision
  • Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
• Warning Letter: Inspection of Pharmaceutical Manufacturing Facility; Barrie Levitt, M. D.

February 4, 2009

• Drugs@FDA Downloadable Data Files (updated)
• FDA issues an Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated]) Drug Information
• Guidance for Industry:
  • Comprehensive List of Guidance Documents
  • New Revised/Withdrawn List for 2009
• New and Generic Drug Approvals
  • Celexa (citalopram hydrobromide) Tablets, Forest Laboratories, Inc., Labeling Revision
  • Celexa (citalopram hydrobromide) Oral Solution, Forest Laboratories, Inc., Labeling Revision
  • Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Eli Lilly and Co., Labeling Revision
  • Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Gelnique (oxybutynin chloride) Gel, Watson Laboratories, Inc., Approval
  • Kapidex (dexlansoprazole) Delayed Release Capsules, Takeda Global Research and Development Center, Inc., Approval
  • Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
  • Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision
  • Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Paxil (paroxetine hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
  • Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • Pexeva (paroxetine mesylate) Tablets, Noven Pharmaceuticals, Inc., Labeling Revision
  • Pristiq (desvenlafaxine succinate) Extended-Release Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Prozac (fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision
  • Prozac (fluoxetine hydrochloride) Oral Solution, Eli Lilly and Co., Labeling Revision
  • Prozac Weekly (fluoxetine hydrochloride) Delayed-Release Capsules, Eli Lilly and Co., Labeling Revision
  • Venlafaxine Hydrochloride Extended-Release Tablets, Osmotica Pharmaceutical Corp., Labeling Revision
  • Zoloft (sertraline hydrochloride) Oral Concentrate, Pfizer, Inc., Labeling Revision
  • Zoloft (sertraline hydrochloride) Tablets, Pfizer, Inc., Labeling Revision
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) (Updated)
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 2008 (Updated)
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008

February 3, 2009

• New and Generic Drug Approvals
  • Amiloride Hydrochloride Tablets, SigmaPharm Laboratories, LLC, Approval
  • Claritin RediTabs (loratadine) Orally Disintegrating Tablet, Schering-Plough HealthCare Products, Manufacturing Change or Addition
  • Cyklokapron (tranexamic acid) Injection, Pharmacia and Upjohn, Labeling Revision
  • Desferal (deferoxamine mesylate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  • Divalproex Sodium Delayed-Release Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Extraneal (icodextrin) Peritoneal Solution, Baxter Healthcare Corp., Package Change
  • Galantamine Hydrobromide Oral Solution, Roxane Laboratories, Inc., Approval
  • Irinotecan Hydrochloride Injection, X-GEN Pharmaceuticals, Inc., Approval
  • Isentress (raltegravir potassium) Tablets, Merck & Co., Inc., Accelerated Approval
  • Methylprednisolone Acetate Injection, Sandoz Canada, Inc., Approval
  • Mysoline (primidone) Tablets, Pharmaceuticals International, Manufacturing Change or Addition
  • Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Risperidone Oral Solution, Teva Pharmaceuticals USA, Approval
  • Tygacil (tigecycline) I.V. Injection, Wyeth Pharmaceutical Inc., Labeling Revision
  • Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Co., LLC, Approval
• Division of Drug Marketing, Advertising, and Communications: Submission Information
• Office of Generic Drugs: January First-Time Generic Drug Approvals

February 2, 2009

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• National Drug Code Directory
• New and Generic Drug Approvals
  • Divalproex Sodium Delayed-Release Capsules, Zydus Pharmaceuticals USA Inc., Approval
  • Gelnique (oxybutynin chloride) Gel, Watson Laboratories, Inc., Approval 
  • Lamotrigine Tablets, Cadista Pharmaceuticals, Inc., Approval
  • Lamotrigine Tablets, Genpharm ULC, Approval
  • Lamotrigine Tablets, Mylan Pharmaceuticals Inc., Approval
  • Lamotrigine Tablets, Wockhardt USA, Inc., Approval
  • Singulair (montelukast sodium) Tablets, Merck and Co, Inc., Labeling Revision
  • Singulair (montelukast sodium) Chewable Tables, Merck and Co, Inc., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck and Co, Inc., Labeling Revision
  • Torsemide Tablets, Hetero Drugs Limited Unit III, Approval
  • Zetia (ezetimibe) Tablets, MSP Singapore Co., LLC, Package Change
• Orange Book Annual Edition
• Orange Book Preface
• Paragraph IV Patent Certifications (updated)
• Postmarket Requirements and Commitments (updated)

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February 6, 2009 Summary Information for: XACT Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL)   February 5, 2009 510(k) Final Decisions - January 2009   February 2, 2009 Luer Misconnections

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