Center for Drug Evaluation and Research

 

October 9, 2008 Drugs Shortages: Cureent Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children October 8, 2008 Drugs@FDA Downloadable Data Files (updated) New and Generic Drug Approvals Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision Avelox In Sodium Chloride 0.8% In Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision Floxin (ofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision Levaquin (levofloxacin) Oral Solution, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision Levaquin (levofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision Levaquin In Dextrose 5% In Plastic Container (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision October 7, 2008 FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information Guidance for Industry: PDUFA Pilot Project: Proprietary Name Review (finalized) [PDF] New and Generic Drug Approvals Arsenic Trioxide Injection, Teva Parenteral Medicines, Inc., Tentative Approval Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision Cipro In Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corp., Labeling Revision Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, USA, Inc., Package Change Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval Primidone Tablets, Dr. Reddy's Laboratories, Ltd., Approval Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision Warning Letter: YAZ (drospirenone and ethinyl estradiol) Tablets October 6, 2008 Emergency Use Authorization (EUA) for the Pre-Event Provision and Potential Use of Doxycycline Hyclate Tablet Emergency Kits for Inhalational Anthrax Inactive Ingredient Database (updated) Download Search New and Generic Drug Approvals Bromocriptine Mesylate Tablets, Paddock Laboratories, Inc., Approval Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision Galantamine Hydrobromide Extended-release Capsules , Barr Laboratories, Inc., Approval Hylenex[rDNA origin] (hyaluronidase [rDNA origin]) Injection, Halozyme Therapeutics Inc., Labeling Revision Nitrolingual (nitroglycerin) Spray, Sciele Pharma, Inc., Package Change October 3, 2008 Drug Development and Drug Interactions (updated) Drug Safety Oversight Board Meeting, September 18, 2008, Public Summary October 2, 2008 Drugs@FDA Downloadable Data Files (updated) Guidance for Industry: Comprehensive List of Guidance Documents Guidance for Industry: New/Revised/Withdrawn List for 2008 Investigational Human Drugs: Clinical Investigator Inspection List (updated) Search Download New and Generic Drug Approvals Curosurf (poractant alpha) Intratracheal Suspension, Dey, L.P., Labeling Revision Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval EpiPen and Epi E Z Pen Jr (epinephrine) Intramuscular Injection, Meridian Medical Technologies Inc., Labeling Revision Exubera (insulin human [rDNA origin]) Inhalation Powder, Labeling Revision Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Patient Population Altered Videx Ec (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Co., Patient Population Altered Warning Letter: Mirapex (pramipexole dihydrochloride) October 1, 2008 Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial) (updated) New and Generic Drug Approvals Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision Promethazine Hydrochloride Injection, Wockhardt USA, Inc., Approval Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated) Paragraph IV Patent Certifications (updated)   View Earlier News     Back to Top   Other News Digests… FDA - CBER | Today's Health & Pharma News | Drug Thesaurus | DMFs | Search | Site Map   © 2008 Betterchem.com