Coronary Artery Disease

• FDA approval · 2018-05-25
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC. The approval indicates regulatory…

• 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 · 2018-04-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate filed by PD-Rx Pharmaceuticals, Inc. The action concerns a supplemental appr…

• FDA approval · 2018-03-14
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for amlodipine besylate filed by Zydus Pharmaceuticals USA Inc. The action confirms approval of …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2018-03-09
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Brilinta (ticagrelor) submitted by AstraZeneca Pharmaceuticals LP.

• 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 · 2017-10-31
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for PLAVIX (clopidogrel) submitted by Sanofi-Aventis U.S. LLC. The approval concerns changes to the …

• FDA approval · 2017-04-17
  FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)

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

• FDA approval · 2017-02-03
  FDA Approved: PITAVASTATIN — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved an original ANDA for pitavastatin calcium from Upsher-Smith Laboratories, making a generic pitavastatin product available.

• 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 · 2016-07-22
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for BRILINTA (ticagrelor) submitted by AstraZeneca Pharmaceuticals LP. The action concerns a supplem…

• FDA approval · 2016-03-02
  FDA Approved: KENGREAL — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for KENGREAL (cangrelor) from Chiesi USA, Inc., resulting in an updated labeling for the product.

• FDA approval · 2016-02-03
  FDA Approved: AMMONIA N 13 — Original Application (Massachusetts General Hospital)

  FDA approves the original application for Ammonia N-13, a radiopharmaceutical used in PET imaging to assess myocardial perfusion in suspecte…

• FDA approval · 2016-01-10
  FDA Approved: KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI — Supplemental Application (Cardinal Health 414, LLC)

  FDA approved a supplemental application for the KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (Cardinal Health 414, LLC). This updat…

• FDA approval · 2015-11-30
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for pravastatin sodium from Teva Pharmaceuticals USA, Inc., authorizing a generic pravastatin produc…

• FDA approval · 2015-11-09
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic) by Mylan Pharmaceuticals, confirming an additional aspect of its …

• FDA approval · 2015-11-02
  FDA Approved: AMMONIA N 13 — Original Application (PETNET Solutions, Inc.)

  FDA approved Ammonia N-13 from PETNET Solutions as an original-application radiopharmaceutical for PET imaging to assess myocardial perfusio…

• FDA approval · 2015-10-19
  FDA Approved: AMMONIA N 13 — Original Application (3D Imaging Drug Design and Development LLC)

  FDA approved AMMONIA N-13 for PET myocardial perfusion imaging under an Original Application from 3D Imaging Drug Design and Development LLC…

• FDA approval · 2015-10-15
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• FDA approval · 2015-10-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for amlodipine besylate as a generic product under an ANDA, expanding its availabilit…

• FDA approval · 2015-08-14
  FDA Approved: AMMONIA N-13 — Original Application (Precision Nuclear LLC)

  FDA approves AMMONIA N-13 from Precision Nuclear LLC through an Original Application for use as a PET radiotracer.

• FDA approval · 2015-07-28
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, for a generic version of clopidogrel.

• FDA approval · 2015-07-16
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA lists a supplemental application for Plavix (clopidogrel) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-06-23
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved the Original Application for Fludeoxyglucose F-18 (FDG F-18) radiopharmaceutical for PET imaging, establishing its labeling and…