Coronary Artery Disease

• FDA approval · 2022-07-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.

• FDA approval · 2022-07-08
  FDA Approved: ISOSORBIDE DINITRATE — Original Application (Advagen Pharma Ltd)

  FDA approved the original application for isosorbide dinitrate, a generic anti-anginal medication, from Advagen Pharma Ltd.

• FDA approval · 2022-05-23
  FDA Approved: REGADENOSON — Original Application (International Medication Systems, Limited)

  FDA approved an original ANDA for Regadenoson by International Medication Systems, Limited, authorizing a generic regadenoson product for us…

• FDA approval · 2022-05-17
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Technetium Tc-99m Sestamibi, updating its labeling and approved use in diagnostic myocardial per…

• FDA approval · 2022-04-11
  FDA Approved: REGADENOSON — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s generic Regadenoson for use as a pharmacologic stress agent in myocardial perfusion imaging to evaluate for coro…

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• FDA approval · 2022-04-11
  FDA Approved: REGADENOSON — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for Regadenoson from Dr. Reddy's Laboratories Inc. as a generic product for pharmacologic stress testi…

• FDA approval · 2022-04-11
  FDA Approved: REGADENOSON — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original (ANDA) application for Regadenoson, a generic pharmacologic stress agent used for myocardial…

• FDA approval · 2022-03-09
  FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)

  FDA approved a supplemental application for MYOVIEW (tetrofosmin) by Medi-Physics Inc. dba GE Healthcare, authorizing an updated use of the …

• FDA approval · 2022-03-07
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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

• FDA approval · 2022-01-26
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for Edenbridge Pharmaceuticals' generic Isosorbide Mononitrate.

• FDA approval · 2021-12-21
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for clopidogrel bisulfate submitted by Dr. Reddy's Laboratories Limited. The action confirms approva…

• FDA approval · 2021-09-07
  FDA Approved: EPTIFIBATIDE — Original Application (Hainan Shuangcheng Pharmaceuticals Co., Ltd.)

  The FDA approved the original ANDA for Eptifibatide from Hainan Shuangcheng Pharmaceuticals Co., Ltd., authorizing a generic version of the …

• FDA approval · 2021-08-31
  FDA Approved: SIMVASTATIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for simvastatin submitted by XLCare Pharmaceuticals Inc., approving changes under the ANDA.

• FDA approval · 2021-07-09
  FDA Approved: TICAGRELOR — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's generic ticagrelor under ANDA 208597.

• FDA approval · 2021-05-28
  FDA Approved: BIVALIRUDIN — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the original application for a generic Bivalirudin product from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2021-05-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, authorizing the atorvastatin calcium product unde…

• FDA approval · 2021-04-14
  FDA Approved: BIVALIRUDIN — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for the generic anticoagulant Bivalirudin from Fresenius Kabi USA, LLC.

• FDA approval · 2021-03-22
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approves Glenmark's diltiazem hydrochloride as an original ANDA; the product is a generic calcium channel blocker indicated for hyperten…

• FDA approval · 2021-02-17
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2021-01-15
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-12-15
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …

• FDA approval · 2020-12-11
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

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

• FDA approval · 2020-09-25
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.

• 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 · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Rosuvastatin Calcium from Rising Pharma Holdings, Inc., enabling this rosuvastatin calcium g…