Coronary Artery Disease

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

  FDA approved a supplemental application for Sandoz Inc. to update/expand the approval of the generic isosorbide dinitrate.

• 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 · 2019-11-20
  FDA Approved: ISOSORBIDE DINITRATE — Original Application (BluePoint Laboratories)

  FDA approved the original application for a generic Isosorbide Dinitrate product from BluePoint Laboratories.

• FDA approval · 2019-11-04
  FDA Approved: PRASUGREL — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for prasugrel, granting approval of a generic prasugrel product.

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• 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…

• FDA approval · 2019-10-01
  FDA Approved: BIVALIRUDIN — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves Dr. Reddy's Laboratories Limited's supplemental application for Bivalirudin, a generic anticoagulant, under an ANDA. The approv…

• FDA approval · 2019-09-26
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories, LLC (ANDA209222).

• FDA approval · 2019-09-23
  FDA Approved: BIVALIRUDIN — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Bivalirudin submitted by Mylan Institutional LLC.

• FDA approval · 2019-09-23
  FDA Approved: BIVALIRUDIN — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for bivalirudin by Meitheal Pharmaceuticals, marking regulatory approval of a modification to the dr…

• FDA approval · 2019-09-20
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for clopidogrel bisulfate manufactured by Aurobindo Pharma Limited, enabling continued marketing…

• FDA approval · 2019-07-25
  FDA Approved: BIVALIRUDIN — Original Application (MAIA Pharmaceuticals, Inc.)

  The FDA approved bivalirudin under an original application from MAIA Pharmaceuticals, labeling it as an anticoagulant for use during certain…

• FDA approval · 2019-04-30
  FDA Approved: NITROGLYCERIN — Original Application (Natco Pharma USA LLC)

  FDA has approved Natco Pharma USA LLC's Nitroglycerin generic under an Original Application (ANDA211604).

• 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 · 2019-04-02
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.

• FDA approval · 2019-03-28
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EFFIENT (prasugrel hydrochloride) from Cosette Pharmaceuticals, Inc., indicating updates to the …

• 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: BIVALIRUDIN — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for BIVALIRUDIN from Civica, Inc., resulting in an approved update to the NDA.

• 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 · 2018-11-20
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for atorvastatin calcium from Zydus Lifesciences Limited, granting generic approval for lowering chole…

• FDA approval · 2018-11-05
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals, LLC's original application for isosorbide mononitrate, a generic product indicated for the prevention …

• 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 · 2018-07-27
  FDA Approved: BIVALIRUDIN — Original Application (Eugia US LLC)

  FDA approved the original application for BIVALIRUDIN by Eugia US LLC, granting a generic version of the anticoagulant for approved indicati…

• FDA approval · 2018-07-16
  FDA Approved: BIVALIRUDIN — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application for generic bivalirudin.