Ischemic Heart Disease

• FDA approval · 2009-12-23
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for LEXISCAN (regadenoson) submitted by Astellas Pharma US, Inc.

• FDA approval · 2009-10-22
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for RAMIPRIL submitted by Chartwell RX, LLC., indicating approval of a supplemental filing related t…

• FDA approval · 2009-04-29
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Original Application (Jubilant Draximage (USA) Inc.)

  FDA approved Jubilant Draximage (USA) Inc.'s original ANDA for Technetium Tc-99m Sestamibi, a radiopharmaceutical used in myocardial perfusi…

• FDA approval · 2009-04-28
  FDA Approved: KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI — Original Application (Cardinal Health 414, LLC)

  FDA approved the original application for a kit to prepare technetium-99m sestamibi for myocardial perfusion imaging, allowing on-site prepa…

• FDA approval · 2009-03-17
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA information on a supplemental application for LEXISCAN (regadenoson) from Astellas Pharma US, Inc., indicating regulatory action on the …

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• FDA approval · 2008-10-01
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for nitroglycerin by Prasco Laboratories, updating the NDA with additional labeling/indication.

• FDA approval · 2008-09-30
  FDA Approved: CARVEDILOL — Supplemental Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved a supplemental application for carvedilol from Unichem Pharmaceuticals (USA), Inc., expanding labeling for this product.

• FDA approval · 2008-09-22
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Original Application (Curium US LLC)

  FDA approved the original application for Technetium Tc-99m Sestamibi (Curium US LLC) for myocardial perfusion imaging to evaluate suspected…

• FDA approval · 2008-04-30
  FDA Approved: CARDIOLITE — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for Cardiolite, updating its labeling and regulatory status for the radiopharmaceutical used in myoc…

• FDA approval · 2008-02-21
  FDA Approved: ISOSORBIDE DINITRATE — Supplemental Application (Sandoz Inc.)

  FDA has approved a supplemental application for Isosorbide Dinitrate by Sandoz Inc., indicating a regulatory update for this generic product…

• FDA approval · 2007-11-13
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for carvedilol, indicating an approved labeling change for the drug.

• FDA approval · 2007-10-22
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Carvedilol on an original application by Dr. Reddy's Laboratories Limited (generic carvedilol).

• FDA approval · 2007-08-23
  FDA Approved: AMMONIA N 13 — Original Application (THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH)

  FDA approved AMMONIA N 13 (NH3N13), an ammonia-13 radiopharmaceutical for PET imaging, derived from the original NDA submitted by The Feinst…

• FDA approval · 2006-07-27
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for TOPROL XL (metoprolol succinate) from Melinta Therapeutics, LLC. The approval updates the pr…