• FDA has issued a public health advisory to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. FDA News | Public Health Advisory | Podcast | Availability

May 29, 2008

• Office of Generic Drugs: Model Bioequivalence Data Summary Tables and ANDA Checklist for Completeness and Acceptability
• New and Generic Drug Approvals
  • Cetirizine Hydrochloride Syrup, Teva Pharmaceuticals USA, Approval
  • Escitalopram Oxalate Tablets, Apotex Corp., Tentative Approval
  • HEPSERA (adefovir dipivoxil) Tablets, Gilead Sciences, Inc., Labeling Revision
  • Topiramate Tablets, Cipla Ltd., Tentative Approval
• Resolved Drug Shortage: Leukine (sargramostim)

May 28, 2008

• Drugs@FDA Downloadable Data Files (updated)
• FDA proposes a new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding. FDA News
• New and Generic Drug Approvals
  • Benazepril Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
  • Benazepril Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval
  • CANASA (mesalamine) Suppository, Axcan Scandipharma Inc., Package Change
  • Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline Consumer Healthcare, Formulation Revision
  • Dexedrine (dextroamphetamine sulfate) Extended-Release Capsules, GlaxoSmithKline, Labeling Revision
  • Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Lansoprazole Delayed-Release Capsules, TEVA Pharmaceuticals USA, Tentative Approval
  • Metformin Hydrochloride Tablets, Glenmark Pharmaceuticals Inc., USA, Approval
  • Omeprazole Delayed-Release Capsules, Dr. Reddy's Laboratories, Ltd., Tentative Approval
  • Rifampin Injection, Akorn-Strides, LLC, Approval

May 27, 2008

• Residual Solvents Acceptability Letter

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May 30, 2008 Federal Register: Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters.  Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability.  Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability.  Federal Register: General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device.  Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability. Federal Register: Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System. Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Minutes   May 29, 2008 Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications   May 28, 2008 Federal Register: Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices; Request for Comments.    May 27, 2008 Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Other Summary Information for: Zenith TX2 Thoracic TAA Endovascular Graft with the H&LB One-Shot Introduction System

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