Coronary Artery Disease

• FDA label_change · 2018-05-31
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for LEXISCAN (regadenoson), resulting in changes to the drug's labeling.

• FDA label_change · 2015-09-03
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Brilinta (ticagrelor) filed by AstraZeneca, resulting in a labeling update for the drug.

• FDA label_change · 2014-03-29
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental labeling change for Lexiscan (regadenoson) from Astellas Pharma US, updating the product labeling.

• FDA label_change · 2013-10-16
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Effient (prasugrel hydrochloride) submitted by Cosette Pharmaceuticals, Inc., associated with la…

• FDA label_change · 2013-03-08
  FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)

  FDA approved a supplemental application for Myoview (technetium-99m tetrofosmin) to update its labeling after review.

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• FDA label_change · 2012-11-16
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NORVASC (amlodipine besylate) filed by Viatris Specialty LLC.

• FDA label_change · 2012-02-08
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CardioGen-82 (rubidium chloride RB-82) to update its labeling.

• FDA label_change · 2011-05-09
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Norvasc (amlodipine besylate) filed by Viatris Specialty LLC. This action updates the produc…

• FDA label_change · 2010-04-22
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) from Organon LLC to update the product labeling.

• FDA label_change · 2010-02-04
  FDA Approved: ADENOSINE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Adenosine from Mylan Institutional LLC, resulting in changes to the product labeling.

• FDA label_change · 2007-10-31
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NORVASC (amlodipine besylate) by Viatris Specialty LLC, resulting in changes to the labeling…