Ischemic Heart Disease

• FDA label_change · 2024-11-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Metoprolol Tartrate from Fresenius Kabi USA, LLC, indicating approved changes to labeling or for…

• FDA label_change · 2022-01-12
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) to update the labeling, submitted by Melinta Therapeutics, LLC.

• FDA label_change · 2019-08-07
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Bisoprolol Fumarate by Unichem Pharmaceuticals (USA), Inc., resulting in a labeling change for t…

• 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 · 2017-09-14
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC, typically involving a label change or n…

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• 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.

• 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.