News - Drug Approvals - Meetings

 

Drug Approvals

July 17, 2009

• • Sumavel DosePro (sumatriptan) Injection, Zogenix, Inc., Approval
  • Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indication

 

July 16, 2009

• • Aleve Liquid Gels (naproxen sodium) Capsules, Banner Pharmacaps Inc., Labeling Revision
  • Cardura (doxazosin mesylate) Tablets, Pfizer, Inc., Labeling Revision
  • Depo-SubQ Provera 104 (medroxyprogesterone acetate) Subcutaneous Injection, Pharmacia & Upjohn Co., Controlled Supplement
  • DITROPAN (oxybutynin chloride )Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
  • DITROPAN XL (oxybutynin chloride) Extended-Release Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Bausch & Lomb, Inc., Approval
  • Hectorol (doxercalciferol) Capsules, Genzyme Corp., Control Supplement
  • Hytrin (terazosin hydrochloride) Tablets, Abbott Laboratories, Labeling Revision
  • Liothyronine Sodium Tablets, Mylan Pharmaceuticals Inc., Approval
  • Lopid (gemfibrozil) Tablets, Pfizer, Inc., Labeling Revision
  • Nicotine Polacrilex Lozenges, Perrigo R&D Co., Approval
  • Novolog (insulin aspart [rDNA origin]) Injection, Novo Nordisk, Inc., Expiration Date Change
  • Omeprazole Delayed-Release Tablets, 20 mg, Dexcel Pharma Technologies Limited, Labeling Revision
  • Polyethylene Glycol 3350 IV Powder, Mylan Pharmaceuticals, Inc., Tentative Approval
  • Rilutek (riluzole) Tablets, Sanofi Aventis U.S., L.L.C., Labeling Revision

 

July 14, 2009

• • Advil Liqui-Gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Manufacturing Change or Addition
  • Agrylin (anagrelide hydrochloride) Capsules, Shire Development, Inc., Labeling Revision
  • Calan (verapamil hydrochloride) Tablets, G. D. Searle, LLC, Labeling Revision
  • Diabeta (glyburide) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision
  • Effient (prasugrel) Tablets, Eli Lilly and Co., Approval
  • Eurax (crotamiton) Lotion, Ranbaxy, Package Change
  • Flecainide Acetate Tablets, Apotex Inc., Approval
  • Fosinopril Sodium and Hydrochlorothiazide Tablets, Aurobindo Pharma Ltd., Approval
  • Fosinopril Sodium and Hydrochlorothiazide Tablets, InvaGen Pharmaceuticals Inc., Approval
  • Galantamine Hydrobromide Tablets, TEVA Pharmaceuticals, Approval
  • Ibuprofen Capsules, Dr. Reddy’s Laboratories, Ltd., Approval
  • Minipress (prazosin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
  • Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Sumatriptan Succinate Subcutaneous Injection, JHP Pharmaceuticals, LLC, Approval
  • Technetium Tc 99m Sestamibi (technetium tc-99m sestamibi kit) Injection, Pharmalucence, Inc., Approval 

• Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, July 29, 2009 and July 30, 2009, Silver Spring, Maryland.  Meeting Information
• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• Providing Effective Information to Consumers about Prescription Drug Risks and Benefits; Public Workshop, September 24-25, 2009, Gaithersburg, MD 20877. Meeting Information
• CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, MD.