Coronary Syndrome

• FDA approval · 2020-07-20
  FDA Approved: PRASUGREL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for prasugrel submitted by Aurobindo Pharma Limited, granting approval of a generic prasugrel produc…

• FDA approval · 2020-07-17
  FDA Approved: CLOPIDOGREL — Original Application (POLYGEN PHARMACEUTICALS INC.)

  FDA approves Polygen Pharmaceuticals' original ANDA for a generic clopidogrel product.

• FDA approval · 2020-07-15
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' generic heparin sodium (Original Application) as an injectable anticoagulant. It covers the same indi…

• FDA approval · 2020-06-24
  FDA Approved: PRASUGREL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application from Mylan Pharmaceuticals for prasugrel, enabling a generic prasugrel product. The indication c…

• FDA approval · 2020-04-07
  FDA Approved: TICAGRELOR — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original application for ticagrelor from Novadoz Pharmaceuticals LLC. Ticagrelor is an antiplatelet medication used to redu…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2020-04-06
  FDA Approved: TICAGRELOR — Original Application (Oryza Pharmaceuticals, Inc.)

  FDA approved the original application for ticagrelor by Oryza Pharmaceuticals, Inc., authorizing a generic ticagrelor product. Ticagrelor is…

• FDA approval · 2020-03-19
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Italfarmaco SpA)

  FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Italfarmaco SpA.

• FDA approval · 2020-02-05
  FDA Approved: TICAGRELOR — Supplemental Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Ticagrelor from Hisun Pharmaceuticals USA, Inc., confirming approval of the generic ticagrel…

• FDA approval · 2019-12-13
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for Clopidogrel Bisulfate from Radha Pharmaceuticals, Inc., confirming approval of their generic pro…

• EMA approval · 2019-11-13
  EMA Authorised: Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) (clopidogrel;acetylsalicylic acid) — Sanofi-Aventis Groupe

  European Medicines Agency authorised a clopidogrel and acetylsalicylic acid combination product (Zentiva/DuoCover) for acute coronary syndro…

• FDA approval · 2019-11-06
  FDA Approved: CLOPIDOGREL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for clopidogrel under ANDA090844, finalizing an approval for its gen…

• FDA approval · 2019-11-04
  FDA Approved: PRASUGREL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application from Aurobindo Pharma Limited for prasugrel, providing a generic version of the antiplatelet drug us…

• FDA approval · 2019-11-04
  FDA Approved: PRASUGREL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for prasugrel (generic) under ANDA205987, granting approval for the generic prasug…

• 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.

• 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 · 2019-09-23
  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 · 2019-09-12
  FDA Approved: CLOPIDOGREL — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for clopidogrel from Amneal Pharmaceuticals LLC under ANDA 203751, confirming changes to the approve…

• FDA approval · 2019-08-07
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, indicating a supplemental approval …

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' supplemental application for clopidogrel bisulfate, approving changes to the product's labeling.

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for clopidogrel bisulfate by Sun Pharmaceutical Industries, Inc. The approval covers the generic…

• 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 · 2019-05-16
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  The FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc.