Coronary Artery Disease

• FDA approval · 2011-06-22
  FDA Approved: THALLOUS CHLORIDE TL 201 — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Thallous chloride TL 201 from Curium US LLC, indicating an updated or expanded regulatory cleara…

• FDA approval · 2011-06-03
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited’s Original Application for Isosorbide Mononitrate, a generic nitrate used to prevent angina pec…

• FDA approval · 2011-01-05
  FDA Approved: AMMONIA N 13 — Supplemental Application (THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH)

  FDA approved a supplemental application for Ammonia N 13 (NH3N13) from The Feinstein Institutes for Medical Research, updating its labeling …

• FDA approval · 2010-07-29
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CARDIOGEN-82 (Rubidium-82 chloride RB-82) submitted by Bracco Diagnostics Inc.

• FDA approval · 2010-07-12
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Nitrostat (nitroglycerin) submitted by Viatris Specialty LLC, resulting in an updated labeli…

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• FDA approval · 2010-06-30
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for amlodipine besylate by Aurobindo Pharma Limited as a generic product.

• FDA approval · 2010-05-03
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin submitted by Carlsbad Technology, Inc.

• FDA approval · 2010-04-07
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Original Application (Oxford Pharmaceuticals, LLC)

  FDA approved the Original Application for amlodipine besylate 2.5 mg by Oxford Pharmaceuticals, LLC.

• 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 · 2009-04-29
  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 …

• FDA approval · 2009-03-12
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals' amlodipine besylate (generic) product, signaling regulatory approval for t…

• FDA approval · 2009-02-26
  FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)

  The FDA approved a supplemental application for MYOVIEW (tetrofosmin) submitted by Medi-Physics Inc. dba GE Healthcare.

• 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 · 2008-04-10
  FDA Approved: LEXISCAN — Original Application (Astellas Pharma US, Inc.)

  FDA approved LEXISCAN (regadenoson) under its original NDA from Astellas for pharmacologic stress imaging to evaluate suspected coronary art…

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

  The FDA approved a supplemental application for Sandoz Inc.'s isosorbide dinitrate product.

• FDA approval · 2008-01-15
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for pravastatin sodium by Aurobindo Pharma Limited, confirming a generic pravastatin product. The drug…

• FDA approval · 2007-12-28
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for pravastatin sodium submitted by Cipla USA Inc., signaling an additional regulatory approval for …

• 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 · 2007-05-11
  FDA Approved: PRAVASTATIN SODIUM — Original Application (CIPLA USA INC.)

  FDA approved a generic pravastatin sodium product (Pravastatin Sodium) from Cipla USA Inc. through an Original Application (ANDA). This mark…

• FDA approval · 2007-03-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for pravastatin sodium submitted by Teva Pharmaceuticals USA, Inc. under ANDA 076056. The action rel…