• New and Generic Drug Approvals
  • AUGMENTIN (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
  • Bethanechol Chloride Tablets, Lannett, Approval
  • Merrem I.V.(meropenem) Injection, AstraZeneca Pharma, Labeling Revision

March 27, 2008

• FDA issues a Communication about an Ongoing Safety Review of Regranex (marketed as Becaplermin).
• FDA issues an Early Communication about an Ongoing Safety Review of Ziagen (marketed as Abacavir) and Videx (marketed as Didanosine).
• FDA issues an Early Communication about an Ongoing Safety Review of Montelukast (marketed as Singulair).
• New and Generic Drug Approvals
  • Cefprozil Tablets, Apotex, Approval
  • Fenofibrate Tablets, IMPAX Labs, Approval
  • REYATAZ (atazanavir sulfate) Capsules, Bristol-Myers Squibb, Patient Population Altered
  • Ventolin HFA (albuterol sulfate) Inhalation Aerosol, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support

March 26, 2008

• Drugs@FDA Downloadable Data Files (updated)
• FDA releases information on Risk Evaluation and Mitigation Strategies (REMS).
• Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies [PDF]
• New and Generic Drug Approvals
  • AMRIX (cyclobenzaprine  hydrochloride) Extended-Release Capsules, Anesta AG, Labeling Revision
  • Depakote (divalproex sodium) Sprinkle Capsules, Abbott Labs, Patient Population Altered
  • Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Labs, Patient Population Altered
  • INVANZ (ertapenem sodium) Injection, Merck & Co., Labeling Revision
  • Tigan (trimethobenzamide hydrochloride) Capsules, King Pharma, Labeling Revision
• Warning Letters
  • Avinza, King Pharmaceuticals, Inc.
  • Inspection, Coast Institutional Review Board

March 24, 2008

• Guidance for Industry: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [PDF]
• On March 21, 2008, B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). MedWatch Safety Information
• New and Generic Drug Approvals
  • Fioricet w/Codeine Capsules, Watson Labs, Labeling Revision
  • Gabapentin Tablets, Zydus Pharma, Tentative Approval
  • Glycopyrrolate Tablets, Indicus Pharma, Approval
  • Ondansetron Injection, Taro Pharma, Approval
  • Phentermine Hydrochloride Capsules, KVK-Tech, Approval
  • Prozac (fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision
  • Prozac (fluoxetine HCl) Solution, Eli Lilly & Co., Labeling Revision
  • Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly & Co., Labeling Revision
  • Stavudine/Lamivudine/Nevirapine Tablets, Strides Arcolab, Tentative Approval
  • Symbyax (olanzapine/fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision

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March 28, 2008 Consumer Information on: Dako TOP2A FISH pharmDx Kit - P050045 Consumer Information on: FreeStyle Navigator Continuous Glucose Monitoring System - P050020   March 27, 2008 Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.   March 26, 2008 FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries  Federal Register: Global Harmonization Task Force, Study Group 4; Final Document; Availability. Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies (Companion Document) Guidance for Industry: Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies   March 24, 2008 Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

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