Cardiovascular Disease

• FDA approval · 2024-12-05
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium from Mylan Pharmaceuticals Inc., authorizing the continued marketing of the…

• FDA approval · 2024-03-01
  FDA Approved: DEFINITY — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for DEFINITY (perflutren) from Lantheus Medical Imaging, Inc., resulting in updated labeling and/or …

• FDA approval · 2024-02-16
  FDA Approved: ICOSAPENT ETHYL — Original Application (Northstar Rx LLC)

  FDA approved the original application for icospent ethyl (ICOSAPENT ETHYL) from Northstar Rx LLC, a generic version of the prescription ther…

• FDA approval · 2023-09-12
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for JARDIANCE (empagliflozin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2023-07-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for atorvastatin calcium from Quallent, indicating a new approval-related action for this generic st…

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• FDA approval · 2023-06-02
  FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pitavastatin from Aurobindo Pharma Limited (ANDA206015).

• FDA approval · 2022-11-03
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lepu Pharmaceutical Technology Co., Ltd.)

  FDA approves the original application for atorvastatin calcium (generic) from Lepu Pharmaceutical Technology Co., Ltd. The approval adds a g…

• 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 · 2020-10-23
  FDA Approved: EZETIMIBE — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved ScieGen Pharmaceuticals' original (ANDA) application for ezetimibe as a generic cholesterol-lowering medication.

• FDA approval · 2020-08-18
  FDA Approved: INVOKANA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVOKANA (canagliflozin) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2020-07-24
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  The FDA approved a supplemental application for ramipril (generic ramipril) filed by Chartwell RX, LLC., under ANDA 078745.

• FDA approval · 2020-06-24
  FDA Approved: AMMONIA N 13 — Supplemental Application (3D Imaging Drug Design and Development LLC)

  FDA approved a supplemental application for AMMONIA N 13, a PET imaging radiopharmaceutical, submitted by 3D Imaging Drug Design and Develop…

• FDA approval · 2019-04-09
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for OZEMPIC (semaglutide) from Novo Nordisk.

• FDA approval · 2018-12-31
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for SIMVASTATIN from Accord Healthcare, Inc., updating the approved product. This action concerns a …

• FDA approval · 2018-12-21
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' atorvastatin calcium as an original generic application, authorizing a new generic version of atorvast…

• FDA approval · 2017-12-13
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Jardiance (empagliflozin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc., resulting in …

• FDA approval · 2016-10-31
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved Cranbury Pharmaceuticals' rosuvastatin calcium through an Original Application for an Abbreviated New Drug Application (ANDA), …

• FDA approval · 2016-05-11
  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.

• FDA approval · 2016-02-26
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Supplemental Application (Massachusetts General Hospital)

  FDA approved a supplemental application for Fludeoxyglucose F-18 submitted by Massachusetts General Hospital to support its use as a radioph…

• FDA approval · 2015-09-03
  FDA Approved: TELMISARTAN — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for telmisartan from Aurobindo Pharma Limited, a generic ARB for hypertension. The approval permits ma…

• FDA approval · 2015-06-26
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Jardiance (empagliflozin) by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2015-06-23
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute)

  FDA approved the original application for Fludeoxyglucose F-18 as a radiopharmaceutical imaging agent for PET scans, developed by the Univer…

• FDA approval · 2015-05-01
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (Biomedical Research Foundation of Northwest Louisiana)

  FDA approved Fluorodeoxyglucose F-18 as a diagnostic radiopharmaceutical for positron emission tomography (PET) imaging under an original ap…

• FDA approval · 2015-02-17
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for a generic fixed-dose combination tablet of amlodipine besylate and atorvastatin calcium (AML…

• FDA approval · 2012-11-28
  FDA Approved: FLUDEOXYGLUCOSE F18 — Supplemental Application (THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH)

  FDA has approved a supplemental application for Fludeoxyglucose F-18, a PET radiopharmaceutical, reflecting an update to its labeling and/or…