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U.S. Food & Drug Administration (FDA)

New and Generic Drug Approvals

  • Calan (verapamil hydrochloride) Tablets, Pfizer, Incorporated, Labeling Revision
  • Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision
  • Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision
  • Covera HS (verapamil hydrochloride) Extended-Release Tablets, Pfizer, Incorporated, Labeling Revision
  • Doral (quazepam) Tablets, Questcor Pharma., Inc., Labeling Revision
  • Hydromorphone Hydrochloride Injection, Akorn, Inc., Approval
  • Lidoderm (lidocaine) Patch, Teikoku Pharma USA, Inc., Labeling Revision
  • Oraqix (lidocaine and prilocaine) Periodontal Gel, Dentsply Pharmaceutical, Inc., Labeling Revision
  • Ortho Evra (norelgestromin and ethinyl estradiol) Patch, Johnson & Johnson Pharmaceuticals Research, Labeling Revision
  • Pancreaze (pancrelipase) Delayed-Release Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Approval
  • Anthelios 40 (ecamsule, avobenzone, octocrylene, and titanium dioxide) Cream, L’Oreal Products, Inc., Labeling Revision
  • Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser Inc., Labeling Revision
  • Didanosine Delayed-Release Capsules, Matrix Laboratories Limited, Approval
  • Donepezil Hydrochloride Orally Disintegrating Tablets, Barr Laboratories, Inc., Tentative Approval
  • Granisetron Hydrochloride Injection, Sagent Strides, Approval
  • Pramipexole Dihydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Uroxatral (alfuzosin hydrochloride) Extended-Release Tablets, sanofi-aventis U.S., LLC, Labeling Revision
  • Venlafaxine Hydrochloride Tablets, Auroblndo Pharma Limited, Approval
  • Yasmin (drospirenone and ethinyl estradiol) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
  • Yaz (drospirenone and ethinyl estradiol) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
  • Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision

News & Events

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  • FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>
  • Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>
  • GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
  • FDA Approves Mylan’s Drug Applications Mylan Inc. Monday announced that its subsidiary Mylan Ph... Read more>>
  • Novozymes Partnering With ProMetic Life Sciences Inc.Drug Discovery & Development - April 0... Read more>>
  • in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and... Read more>>
  • Food and Drug Administration NOTICES Meetings:   Internationa... Read more>>
  • T Cell Proliferation Assays ProImmune Ltd, a leader in epitope discovery, immunogenicity, an... Read more>>
  • Key Protein Aids In DNA Repair Scientists have shown in multiple contexts that DNA damage ov... Read more>>