Coronary Artery Disease

• 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 · 2013-12-12
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC.

• 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.

• FDA approval · 2013-11-29
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves an original ANDA for AMLODIPINE AND ATORVASTATIN (Mylan Pharmaceuticals Inc.), a generic fixed-dose combination product.

• FDA approval · 2013-10-30
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

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• FDA approval · 2013-10-16
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.

• FDA approval · 2013-09-30
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin submitted by Accord Healthcare, Inc.

• FDA approval · 2013-09-20
  FDA Approved: NITROGLYCERIN LINGUAL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Nitroglycerin Lingual as a generic product under an original ANDA from Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2013-08-30
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for amlodipine besylate from Epic Pharma, enabling the generic product to be marketed.

• 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 · 2013-04-04
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application for clopidogrel bisulfate submitted by Dr. Reddy's Laboratories Inc, for their generic clopidogr…

• 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 · 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 · 2012-11-26
  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 · 2012-11-15
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) filed by Organon LLC.

• FDA approval · 2012-09-28
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Simvastatin from Accord Healthcare, Inc., updating the approval status under the ANDA.

• FDA approval · 2012-07-17
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approves Dr. Reddy's Laboratories Limited's generic atorvastatin calcium for lipid-lowering therapy under an original ANDA.

• FDA approval · 2012-07-17
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as an original ANDA, enabling a generic atorvastatin calcium product.

• FDA approval · 2012-07-12
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for pravastatin sodium (Quallent), resulting in an approved change to the generic product.

• FDA approval · 2012-01-12
  FDA Approved: THALLOUS CHLORIDE TL 201 — Supplemental Application (Curium US LLC)

  The FDA approved a supplemental application for THALLOUS CHLORIDE TL 201 (Curium US LLC) to support its use in myocardial perfusion imaging …

• FDA approval · 2011-10-17
  FDA Approved: PERINDOPRIL ERBUMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for PERINDOPRIL ERBUMINE from Aurobindo Pharma Limited (ANDA) to market the generic product.

• FDA approval · 2011-10-06
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ZOCOR (simvastatin) filed by Organon LLC.

• 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 · 2011-09-23
  FDA Approved: LEXISCAN — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Lexiscan (regadenoson) from Astellas Pharma US, Inc., to update the product labeling.

• FDA approval · 2011-07-26
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

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