News Feed

June 17, 2009

• Drug Shortages: Drugs to be Discontinued: Inversine (mecamylamine hydrochloride) Tablets, 2.5 mg
• Drugs@FDA Download File (updated)
• Information for Healthcare Professionals: Cefepime (marketed as Maxipime)

June 16, 2009

• Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
• FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

June 15, 2009

• Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
• FDA Issues Public Health Advisory Regarding Levemir Insulin
• Paragraph IV Patent Certifications (updated)

 

Drug Approvals

June 19, 2009

• • Exidine (chlorhexidine gluconate) Topical Aerosol, Xttrium Laboratories, Inc., Package Change
  • Glumetza (metformin hydrochloride) Extended-Release Tablets, Depomed, Inc., Labeling Revision
  • Montelukast Sodium Tablets, Roxane Laboratories, Inc., Tentative Approval
  • Novolin R (insulin [rDNA origin]) Injection, NovoNordisk Inc., Labeling Revision
  • Novolin N (insulin susp isophane [rDNA origin]) Injection, NovoNordisk Inc., Labeling Revision
  • Novolin 70/30 (insulin [rDNA origin] and insulin susp isophane [rDNA origin]) Injection, NovoNordisk Inc., Labeling Revision
  • Quetiapine Fumarate Tablets, Dr. Reddy’s Laboratories Ltd., Tentative Approval
  • Tylenol (GelTab) (acetaminophen) Extended-Release Tablets, McNeil Consumer Healthcare, Labeling Revision
  • Zipsor (diclofenac potassium) Capsules, Xanodyne Pharmaceuticals, Inc., Approval

 

June 18, 2009

• • Aralen (chloroquine phosphate) Tablets, Sanofi-Aventis U.S. Inc., Approval
  • BenzaClin (benzoyl peroxide and clindamycin phosphate) Gel, Sanofi-Aventis U.S., Labeling Revision
  • Calcitonin-Salmon Nasal Spray, MDRNA, Inc., Approval
  • Cefoxitin (cefoxitin sodium) Injection, ACS Dobfar S.p.A., Approval
  • Hyzaar (hydrochlorothiazide, losartan and potassium) Tablets, Merck & Co., Inc., Labeling Revision
  • Lamisil AT (terbinafine hydrochloride) Topical Solution, Novartis Consumer Health, Inc., Package Change
  • Levo-T (levothyroxine sodium) Tablets, ALARA Pharmaceutical Corp., Control Supplement
  • Melphalan Hydrochloride Injection, Synerx Pharma, LLC, Approval
  • Natrecor (nesiritide [rDNA origin]) Intravenous Solution, Scios, Inc., Labeling Revision
  • Prezista (darunavir ethanolate) Tablets, Tibotec, Inc., Labeling Revision
  • Zoledronic Acid Injection, Teva Parenteral Medicines, Inc., Tentative Approval 

 

June 17, 2009

• • Cyanokit (hydroxocobalamin) Injection, Merck Santé s.a.s, Labeling Revision
  • Diovan (valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Diuril (chlorothiazide) Oral Suspension, Salix Pharmaceuticals, Inc., Labeling Revision
  • Eraxis (anidulafungin) I.V. Injection, Vicuron Pharmaceuticals Inc., Formulation Revision
  • Folic Acid Tablets, InvaGen Pharmaceuticals Inc., Approval
  • Letrozole Tablets, Roxane Laboratories, Inc., Tentative Approval
  • Omeprazole Magnesium Extended-Release Capsules, Dr. Reddy's Laboratories Ltd., Approval
  • Rocephin (ceftriaxone sodium) Intramuscular I.V. Injection, Hoffman-La Roche, Inc., Labeling Revision
  • Technetium Tc 99m Albumin Aggregated Kit Injection, Draximage, Control Supplement 

 

June 16, 2009

• • Amaryl (glimepiride) Tablets, Sanofi-Aventis U.S., LLC, Labeling Revision
  • Aristospan (triamcinolone hexacetonide) Injection, Sandoz, Inc., Labeling Revision
  • Coly-Mycin S (colistin sulfate, hydrocortisone acetate, neomycin sulfate and thonzonium bromide) Otic Suspension, JHP Pharmaceuticals, Labeling Revision
  • Combivent (ipratropium bromide and albuterol sulfate), Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Cozaar (losartan potassium) Tablets, Merck & Co., Inc., Labeling Revision
  • Endometrin (progesterone) Vaginal Insert, Ferring Pharmaceuticals, Inc., Labeling Revision
  • Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision
  • Trazodone Hydrochloride Tablets, Matrix Laboratories, Ltd., Approval
  • Triamcinolone Acetonide Injection, Sandoz Canada, Inc., Approval
  • Xibrom (bromfenac sodium) Ophthalmic Solution, ISTA Pharmaceuticals, Inc., Labeling Revision

Meetings & Conferences

• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, MD.