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What's New by Date

This page lists new and revised documents posted to the CDER web site. Each listing will remain on this page approximately 30 days. The dates listed indicate the dates of posting to the CDER web site, not the dates of origination or revision. When viewing a document, click your browser's "refresh" or "reload" button to make sure you are seeing the latest version.

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May 11, 2009

May 8, 2009

May 7, 2009

May 6, 2009

May 5, 2009

May 4, 2009

May 1, 2009

  • Drugs@FDA Downloadable Data Files (updated)
  • FDA approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information
  • New and Generic Drug Approvals
    • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation Labeling Revision
    • Avelox (moxifloxacin hydrochloride in NaCl injection) I.V. Injection, Bayer Pharmaceuticals Corporation Labeling Revision
    • Cetirizine Hydrochloride Syrup, Dr. Reddy's Laboratories, Inc., Approval
    • Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation, Labeling Revision
    • Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corporation, Labeling Revision
    • Cipro in Dextrose in Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corporation, Labeling Revision
    • Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corporation, Labeling Revision
    • Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corporation, Labeling Revision
    • Creon (pancrelipase) Delayed-Release Capsules, Solvay Pharmaceuticals, Approval
    • Donepezil Hydrochloride Tablets, Apotex, Inc., Tentative Approval
    • Duraclon (clonidine hydrochloride) Injection, Xanodyne Pharmaceuticals, Inc., Labeling Revision
    • Equetro (carbamazepine) Extended-Release Capsules, Validus Pharmaceuticals, Labeling Revision
    • Ezetimibe Tablets, Glenmark Generics Limited, Tentative Approval
    • Felbatol (felbamate) Tablets and Oral Suspension, Meda Pharmaceuticals, Inc., Labeling Revision
    • Fexofenadine Hydrochloride Tablets, Sandoz, Inc., Tentative Approval
    • Gabitril (tiagabine hydrochloride) Tablets, Cephalon, Inc., Labeling Revision
    • Glycet (miglitol) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
    • Kayexalate (sodium polystyrene sulfonate) Oral or Rectal Powder, Sanofi-Aventis U.S., LLC, Labeling Revision
    • Keppra (levetiracetam) Tablets, UCB, Inc., Labeling Revision
    • Keppra (levetiracetam) Oral Solution, UCB, Inc., Labeling Revision
    • Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Labeling Revision
    • Levofloxacin Ophthalmic Solution, Apotex Inc., Tentative Approval
    • Linezolid Tablets, Glenmark Generics Limited, Tentative Approval
    • Motrin IB (ibuprofen) Tablets, McNeil Consumer Healthcare, Labeling Revision
    • Motrin Junior Strength Tablets, McNeil Consumer Healthcare, Labeling Revision
    • Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Labeling Revision
    • Stavzor (valproic acid) Delayed-Release Capsules, Banner Pharmacaps, Inc., Labeling Revision
    • Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision
    • Topamax (topiramate) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Topamax Sprinkle (topiramate) Capsules, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Velcade (bortezomib) Intravenous Injection, Millennium Pharmaceuticals, Inc., Manufacturing Change or Addition
    • Zonegran (zonisamide) Capsules, Dainippon Pharmaceutical USA Corporation, Labeling Revision
  • Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

April 30, 2009

April 29, 2009

April 28, 2009

  • Manual of Policies and Procedures (MaPP) 5100.4 Scientific Interest Groups: Criteria and Policies
  • Drug Shortages: Current Drug Shortage: Morphine Sulfate Oral Solution (updated)
  • New and Generic Drug Approvals
    • BSS (calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride and sodium citrate) Irrigation Solution, Alcon Laboratories, Inc., Package Change
    • Carbatrol (carbamazepine) Extended-Release Capsules, Shire Development, Inc., Labeling Revision
    • Celontin (methsuximide) Capsules, Pfizer, Inc., Labeling Revision
    • Dilantin-125 (phenytoin) Oral Suspension, Pfizer, Inc., Labeling Revision
    • Neurontin (gabapentin) Capsules, Pfizer, Inc., Labeling Revision
    • Neurontin (gabapentin) Tablets, Pfizer, Inc., Labeling Revision
    • Neurontin (gabapentin) Oral Solution, Pfizer, Inc., Labeling Revision
    • Peganone (ethotoin) Tablets, Ovation Pharmaceuticals, Inc., Labeling Revision
    • Pristiq (desvenlafaxine succinate) Extended-Release Tablets, Wyeth Pharmaceuticals Inc., Control Supplement
    • Tranxene (clorazepate dipotassium) Capsules, Ovation Pharmaceuticals, Inc., Labeling Revision
    • Zarontin (ethosuximide) Capsules, Pfizer, Inc., Labeling Revision
  • The U.S. Food and Drug Administration and the U.S. Substance Abuse and Mental Health Services Administration launched an initiative to help ensure the safe use of methadone. For more information on the campaign, or to download free copies of the educational materials, please visit www.dpt.samhsa.gov/methadonesafety

April 27, 2009

April 24, 2009

April 23, 2009

April 22, 2009

April 21, 2009

  • New and Generic Drug Approvals
    • Aleve-D Sinus & Cold (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer HealthCare Consumer Care, Labeling Revision
    • Doxycycline Tablets, Mutual Pharmaceutical Co., Inc., Approval
    • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision
    • Savella (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Control Supplement

April 20, 2009

April 17, 2009

April 16, 2009

April 15, 2009

April 14, 2009

April 9, 2009

April 8, 2009

 

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Date updated: May 11, 2009

 
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