Ischemic Heart Disease

• FDA approval · 2014-03-04
  FDA Approved: CLOPIDOGREL — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original generic application for clopidogrel bisulfate (clopidogrel).

• FDA approval · 2014-02-07
  FDA Approved: AMMONIA N 13 — Original Application (Washington University School of Medicine)

  FDA approved Ammonia N-13 (NH3N13) from Washington University School of Medicine as an original-application radiopharmaceutical for PET imag…

• FDA approval · 2014-01-09
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Lexiscan (regadenoson) from Astellas Pharma US, Inc., updating the labeling for the pharmaco…

• FDA approval · 2013-12-31
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter Healthcare Company's supplemental NDA for Nitroglycerin in Dextrose, authorizing the nitroglycerin-in-dextrose formulati…

• FDA approval · 2013-12-09
  FDA Approved: AMMONIA N 13 — Original Application (Kreitchman PET Center)

  FDA approved AMMONIA N-13 as a PET imaging radiotracer under an Original Application for cardiovascular imaging.

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• FDA approval · 2013-09-12
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2013-04-22
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  The FDA approved a supplemental application for CardioGen-82 (Rubidium chloride RB-82) from Bracco Diagnostics Inc. for use in myocardial pe…

• FDA approval · 2013-02-25
  FDA Approved: AMMONIA N-13 — Original Application (Cardinal Health 414, LLC)

  FDA approved an original application for Ammonia N-13 (radiopharmaceutical) under an ANDA filed by Cardinal Health 414, LLC.

• FDA approval · 2013-02-01
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter's Supplemental Application for Nitroglycerin in Dextrose, adding this intravenous nitroglycerin formulation to the appro…

• FDA approval · 2012-12-14
  FDA Approved: AMMONIA N 13 — Original Application (SOFIE Co. dba SOFIE)

  FDA approved the original application for AMMONIA N 13 from SOFIE, a radiopharmaceutical used in PET imaging to assess myocardial perfusion.

• FDA approval · 2012-11-30
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EFFIENT (prasugrel hydrochloride) filed by Cosette Pharmaceuticals, Inc.

• FDA approval · 2012-11-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc. for an already authorized product.

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL BISULFATE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' clopidogrel bisulfate as an original application (ANDA), enabling a generic version of the antiplatel…

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's Original Application for clopidogrel bisulfate, enabling a generic version of clopidogrel to be mark…

• FDA approval · 2011-09-30
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for LEXISCAN (regadenoson) from Astellas Pharma US, expanding/updating its labeling.

• FDA approval · 2011-08-17
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for Tenormin (atenolol) from Almatica Pharma LLC.

• FDA approval · 2011-07-06
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) submitted by Waylis Therapeutics LLC. The action finalizes the r…

• FDA approval · 2011-06-22
  FDA Approved: THALLOUS CHLORIDE TL 201 — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Thallous chloride TL 201 from Curium US LLC, indicating an updated or expanded regulatory cleara…

• FDA approval · 2011-04-29
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved a supplemental application for Isosorbide Mononitrate submitted by Edenbridge Pharmaceuticals LLC.

• FDA approval · 2011-02-25
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (PETNET Solutions, Inc.)

  The FDA approved an original application for Fludeoxyglucose F-18 (FDG F-18) as a radiopharmaceutical for PET imaging, submitted by PETNET S…

• FDA approval · 2011-01-05
  FDA Approved: AMMONIA N 13 — Supplemental Application (THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH)

  FDA approved a supplemental application for Ammonia N 13 (NH3N13) from The Feinstein Institutes for Medical Research, updating its labeling …

• FDA approval · 2010-07-29
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CARDIOGEN-82 (Rubidium-82 chloride RB-82) submitted by Bracco Diagnostics Inc.

• FDA approval · 2010-07-12
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Nitrostat (nitroglycerin) submitted by Viatris Specialty LLC, resulting in an updated labeli…

• FDA approval · 2010-05-18
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's supplemental application for clopidogrel bisulfate, a generic version of clopidogrel. The ap…

• FDA approval · 2010-04-16
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EFFIENT (prasugrel hydrochloride) submitted by Cosette Pharmaceuticals, Inc.