Post-myocardial Infarction

• FDA approval · 2025-07-23
  FDA Approved: VOSTALLY — Original Application (Rosemont Pharmaceuticals LLC)

  The FDA approved VOSTALLY (ramipril) from Rosemont Pharmaceuticals LLC through an original application, introducing a branded ramipril produ…

• FDA approval · 2023-07-26
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

• FDA approval · 2022-03-31
  FDA Approved: QUINAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a quinapril hydrochloride generic product manufactured by Aurobindo Pharma Limited.

• CLINICAL_TRIALS withdrawal · 2021-11-26
  Clinical Trial Update: Open-label Extension Study for CLCZ696G2301 (PARADISE-MI) [Phase 3]

  Open-label extension study for CLCZ696G2301 (PARADISE-MI) has been withdrawn, affecting post-myocardial infarction population.

• FDA approval · 2019-09-03
  FDA Approved: VALSARTAN — Supplemental Application (SQUARE PHARMACEUTICALS LIMITED)

  FDA approved a supplemental application for valsartan submitted by Square Pharmaceuticals Limited. This approval pertains to the generic pro…

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• FDA approval · 2016-02-28
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  The FDA has approved a supplemental application for RAMIPRIL, allowing Chartwell RX, LLC to market a RAMIPRIL generic product.

• FDA approval · 2016-02-16
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Ramipril (generic ACE inhibitor) under ANDA 077626, enabling a generic …

• FDA approval · 2015-10-02
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC, approving the controlled-release f…

• FDA approval · 2015-09-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Amici Pharma, Inc)

  FDA approved a supplemental application for enalapril maleate from Amici Pharma, Inc.

• FDA approval · 2015-08-31
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for ramipril (generic ACE inhibitor) under the ANDA, enabling a revised/exp…

• FDA approval · 2015-08-17
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate filed by Northstar RxLLC.

• FDA approval · 2014-09-22
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for carvedilol by Aurobindo Pharma Limited. This represents approval of a generic carvedilol pro…

• FDA approval · 2013-10-18
  FDA Approved: DIOVAN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Diovan (valsartan) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2011-01-12
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for RAMIPRIL (ramipril) from Hikma Pharmaceuticals USA Inc., allowing a generic ramipril product to …

• FDA approval · 2008-12-31
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental abbreviated new drug application for enalapril maleate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals…

• FDA approval · 2008-08-22
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for CARVEDILOL from Dr. Reddy's Laboratories Limited, authorizing its generic carvedilol product for…