February 16, 2007

• FDA updates the Alert and Healthcare Professional Sheet on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp). Information

• New and Generic Drug Approvals

  • Byetta (exenatide) Injection, Amylin Pharma, Control Suppl.

  • Diprivan (propofol) Injectable Emulsion, Abraxis Bioscience, Labeling Revision

  • Disopyramide Phosphate Capsules, Teva Pharma, Control Suppl.

  • Nifedipine Capsules, Actavis, Control Suppl.

  • Venofer (Iron Sucrose) Injection, Luirpold Pharma, Package Change

• Orange Book Current Cumulative Supplement

• Orange Book Information and Data Files

• Orange Book Monthly Additions and Deletions: January 2007

• Orange Book Query

February 15, 2007

• FDA Drug Educational Forum; Public Workshop for Small Business, April 25, 2007. Meeting Information

• Drugs@FDA Downloadable Data Files (updated)

• New and Generic Drug Approvals

  • Actiq (oral transmucosal fentanyl citrate) Lozenge, Cephalon Inc., Patient Population Altered

  • Alli (60 mg orlistat) capsules, GlaxoSmithKline, Approval

  • DUETACT (pioglitazone HCl + glimepiride) fixed-dose combination tablets, Takeda Global, Labeling Revision

  • Effexor (venlafaxine hydrochloride) Immediate Release Tablets, Wyeth Pharma, Labeling Revision

  • Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision

  • Lexiva (fosamprenavir calcium) tablets, GlaxoSmithKline, Labeling Revision

  • Nardil (phenelzine sulfate) Tablets, Pfizer Inc., Package Change

  • Pregnyl (chorionic gonadotropin) Injection, Organon Inc., Labeling Revision

  • Sotalol Hydrochloride Tablets, Mylan Pharma, Approval

February 14, 2007

• Guidance for Industry: Developing Products for Weight Management. Revision 1 [PDF]

• Medication Guides

  • Flector (diclofenac epolamine) template

  • Prevacid NapraPac (lansoprazole)

• Questions and Answers on Ketek (telithromycin)

February 13, 2007

• Public Meeting on Supplements and Other Changes to an Approved Application: Presentations and Transcript

• Questions and Answers on Ketek (telithromycin)

February 12, 2007

• Consumer Healthcare Products Association (CHPA) / FDA Joint Seminar Series

• FDA and Sanofi-aventis agree on an updated label for Ketek (telithromycin), an antibiotic, and to distribute a Medication Guide for patients. Information

• New and Generic Drug Approvals

  • Amoxicillin Capsules, West-Ward Pharma, Approval

  • Oxybutynin Chloride Extended-release Tablets, Mylan Pharma, Tentative Approval

  • Sertraline Hydrochloride Oral Concentrate, Ranbaxy Inc., Approval

  • Sertraline Hydrochloride Tablets, Sandoz Inc., Approval

  • Sertraline Hydrochloride Tablets, Barr Labs, Approval

  • Sertraline Hydrochloride Tablets, Cobalt Pharma, Approval

  • Sertraline Hydrochloride Tablets, Sun Pharma, Approval

  • Sertraline Hydrochloride Tablets, Zydus Pharma, Approval

  • Sertraline Hydrochloride Tablets, Mutual Pharma, Approval

  • Sertraline Hydrochloride Tablets, Myland Pharma, Approval

  • Sertraline Hydrochloride Tablets, Aurobindo Pharma, Approval

  • Sertraline Hydrochloride Tablets, Apotex Inc., Approval

  • Sertraline Hydrochloride Tablets, Actavis Elizabeth, Approval

  • Sertraline Hydrochloride Tablets, InvaGen Pharma, Approval

  • Sertraline Hydrochloride Tablets, Ranbaxy Inc., Approval

  • Sertraline Hydrochloride Tablets, Lupin Ltd., Approval

  • Sertraline Hydrochloride Tablets, Watson Labs, Approval

  • Sertraline Hydrochloride Tablets, Roxane Labs, Approval

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