Ischemic Heart Disease

• FDA approval · 2020-05-12
  FDA Approved: ISOSORBIDE DINITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Isosorbide Dinitrate from Hikma Pharmaceuticals USA Inc., marking an approved modification t…

• FDA approval · 2020-02-20
  FDA Approved: ISOSORBIDE DINITRATE — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for Isosorbide Dinitrate from Sandoz Inc., indicating regulatory approval of a change to the pro…

• FDA approval · 2020-02-05
  FDA Approved: TICAGRELOR — Supplemental Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Ticagrelor from Hisun Pharmaceuticals USA, Inc., confirming approval of the generic ticagrel…

• FDA approval · 2019-12-04
  FDA Approved: CARDIOLITE — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for CARDIOLITE from Lantheus Medical Imaging, Inc., updating labeling and indications for the radiop…

• FDA approval · 2019-10-23
  FDA Approved: KENGREAL — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for KENGREAL (cangrelor) submitted by Chiesi USA, Inc., authorizing the changes included in the supp…

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• FDA approval · 2019-09-12
  FDA Approved: CLOPIDOGREL — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for clopidogrel from Amneal Pharmaceuticals LLC under ANDA 203751, confirming changes to the approve…

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' supplemental application for clopidogrel bisulfate, approving changes to the product's labeling.

• FDA approval · 2019-04-26
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  The FDA approved a supplemental application for CardioGen-82 (rubidium-82 chloride) submitted by Bracco Diagnostics Inc.

• FDA approval · 2019-04-26
  FDA Approved: RUBY-FILL — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for RUBY-FILL (rubidium-82) from Jubilant Radiopharma, expanding its approved use related to PET myo…

• FDA approval · 2019-01-23
  FDA Approved: TICAGRELOR — Original Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved an Original Application (ANDA) for ticagrelor from Hisun Pharmaceuticals USA, Inc., enabling a generic ticagrelor product t…

• FDA approval · 2018-12-21
  FDA Approved: AMMONIA N 13 — Original Application (Ionetix Corporation)

  The FDA approved Ammonia N-13 from Ionetix Corporation under the Original Application, enabling its use as a radiopharmaceutical for PET ima…

• FDA approval · 2018-08-29
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Chartwell RX, LLC)

  FDA approved an original ANDA for isosorbide mononitrate by Chartwell RX, LLC, enabling a generic version of the drug.

• FDA approval · 2018-07-30
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Nitroglycerin submitted by Prasco Laboratories, signaling an approval-related action affecting t…

• FDA approval · 2018-06-19
  FDA Approved: PRASUGREL — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for prasugrel, authorizing a generic version of the antiplatelet medication. …

• FDA approval · 2018-05-11
  FDA Approved: AMMONIA N-13 — Supplemental Application (Precision Nuclear LLC)

  The FDA approved a supplemental application for Ammonia N-13 submitted by Precision Nuclear LLC, updating the use/labeling of this radiophar…

• FDA approval · 2018-05-01
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Supplemental Application (Jubilant Draximage (USA) Inc.)

  FDA approved a supplemental application for Technetium Tc-99m Sestamibi from Jubilant Draximage (USA) Inc. The approval is associated with a…

• FDA approval · 2017-11-22
  FDA Approved: BIVALIRUDIN — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's generic version of bivalirudin, expanding access to the anticoagulant used to prevent clotting during proce…

• FDA approval · 2017-10-16
  FDA Approved: PRASUGREL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic prasugrel product from Aurobindo Pharma Limited, enabling market entry as a generic anti…

• FDA approval · 2017-09-19
  FDA Approved: NITROGLYCERIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for nitroglycerin from Glenmark Pharmaceuticals Inc., USA, granting a generic nitroglycerin product ma…

• FDA approval · 2017-07-10
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Plavix (clopidogrel) by Sanofi-Aventis U.S. LLC, resulting in changes to the product labeling.

• FDA approval · 2017-01-17
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for LEXISCAN (regadenoson) submitted by Astellas Pharma US, Inc., expanding its regulatory use as a …

• FDA approval · 2016-09-02
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Nitroglycerin submitted by Prasco Laboratories, granting regulatory approval for this produc…

• FDA approval · 2016-08-29
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Nitrostat (nitroglycerin) filed by Viatris Specialty LLC.

• FDA approval · 2016-08-22
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NITROGLYCERIN IN DEXTROSE by Baxter Healthcare Company, indicating regulatory approval and label…

• FDA approval · 2016-08-11
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Brilinta (ticagrelor) from AstraZeneca Pharmaceuticals LP.