Coronary Artery Disease

• FDA approval · 2015-06-22
  FDA Approved: KENGREAL — Original Application (Chiesi USA, Inc.)

  The FDA approved KENGREAL (cangrelor) in its original application from Chiesi USA, Inc., authorizing its use as an intravenous antiplatelet …

• FDA approval · 2015-04-09
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Technetium Tc-99m Sestamibi (Curium US LLC), updating its approval-related labeling.

• FDA approval · 2015-03-26
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Brilinta (ticagrelor) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2015-03-23
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Norvasc (amlodipine besylate) submitted by Viatris Specialty LLC to update the labeling.

• FDA approval · 2015-01-27
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for amlodipine besylate, confirming the approval and availability of Epic Pharma, LLC's generic prod…

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• FDA approval · 2015-01-23
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for nitroglycerin submitted by Prasco Laboratories under the existing NDA.

• FDA approval · 2014-12-05
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CardioGen-82 (rubidium chloride RB-82) from Bracco Diagnostics Inc.

• FDA approval · 2014-12-01
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lovastatin by Lupin Pharmaceuticals, Inc., resulting in regulatory approval related to the gener…

• FDA approval · 2014-11-25
  FDA Approved: SIMVASTATIN — Original Application (XLCare Pharmaceuticals Inc.)

  The FDA approved the original application for SIMVASTATIN from XLCare Pharmaceuticals Inc., granting marketing authorization for a generic s…

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (generic statin).

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, updating the approved generic product.

• FDA approval · 2014-11-04
  FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for simvastatin by Micro Labs Limited under ANDA090383, updating the regulatory status of the approv…

• FDA approval · 2014-11-03
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited.

• FDA approval · 2014-10-30
  FDA Approved: AMMONIA N-13 — Original Application (Brigham and Women's Hospital, Inc., The)

  FDA approved Ammonia N-13 under an original application from Brigham and Women's Hospital for use as a radiopharmaceutical in PET myocardial…

• FDA approval · 2014-10-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  The FDA approved Cipla USA Inc.'s supplemental application for pravastatin sodium, confirming approval of a generic pravastatin product.

• FDA approval · 2014-09-19
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for LEXISCAN (regadenoson) submitted by Astellas Pharma US, Inc. This action represents an updat…

• FDA approval · 2014-08-19
  FDA Approved: AMMONIA N 13 — Original Application (The Johns Hopkins University)

  FDA approved AMMONIA N 13 (NH3N13) via an Original Application under an ANDA from The Johns Hopkins University, for use as a radiopharmaceut…

• FDA approval · 2014-07-28
  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 · 2014-07-28
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for the fixed-dose combination of amlodipine and atorvastatin (amlodipi…

• FDA approval · 2014-07-01
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  The FDA approved a supplemental application for Pravastatin Sodium by Cipla USA Inc.

• FDA approval · 2014-06-30
  FDA Approved: ARGATROBAN — Original Application (Mylan Institutional LLC)

  FDA approved a generic Argatroban from Mylan Institutional LLC under ANDA 202626 for use as an anticoagulant in adults with heparin-induced …

• FDA approval · 2014-03-28
  FDA Approved: AMMONIA N 13 — Original Application (UCSF Radiopharmaceutical Facility)

  The FDA approved Ammonia N-13 (NH3N13) from the UCSF Radiopharmaceutical Facility under an Original Application.

• FDA approval · 2014-03-07
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Nitrostat (nitroglycerin) from Viatris Specialty LLC.

• 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…