Atherosclerotic Cardiovascular Disease

• 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 · 2021-05-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA granted supplemental approval for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA.

• FDA approval · 2021-03-17
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for a generic ezetimibe and simvastatin product from Dr. Reddy's Laboratories, authorizing its marke…

• FDA approval · 2021-03-15
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium to allow Aurobindo Pharma Limited to market a generic pravastatin product in …

• FDA approval · 2021-03-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic pravastatin sodium, updating its regulatory status as an approved ge…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-02-26
  FDA Approved: REPATHA — Original Application (Amgen USA Inc.)

  FDA approved Repatha (evolocumab) from Amgen USA Inc. in an original application to lower LDL cholesterol in adults with familial hyperchole…

• FDA approval · 2021-02-23
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for EZETIMIBE AND SIMVASTATIN by Ascend Laboratories, LLC. The approval covers changes under the…

• FDA approval · 2021-02-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for pravastatin sodium (generic pravastatin) under ANDA 076056.

• FDA approval · 2021-02-11
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic Pravastatin Sodium product from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2021-02-01
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin). This represents an approved suppleme…

• 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 · 2020-12-17
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original-application generic fixed-dose combination of ezetimibe and simvastatin.

• 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 · 2020-10-13
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for ATORVASTATIN CALCIUM from Dr. Reddy's Laboratories Limited, granting approval for a generic ator…

• FDA approval · 2020-09-25
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's supplemental application for EZALLOR SPRINKLE (rosuvastatin), adding a sprinkle formulation to the rosuvas…

• 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 · 2020-09-25
  FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Fluvastatin (generic) under the ANDA.

• FDA approval · 2020-09-25
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin (Carlsbad Technology, Inc.) to modify an existing ANDA product.

• FDA approval · 2020-09-25
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Fluvastatin Sodium (generic) filed by Mylan Pharmaceuticals Inc., enabling continued marketi…

• FDA approval · 2020-09-15
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for fluvastatin sodium submitted by Mylan Pharmaceuticals, updating the approved ANDA product.

• FDA approval · 2020-08-19
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approves an original new application for atorvastatin calcium from NIVAGEN Pharmaceuticals, a generic version of atorvastatin indicated …

• FDA approval · 2020-06-24
  FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted a supplemental approval for a generic pitavastatin product from Aurobindo Pharma Limited.

• FDA approval · 2020-06-15
  FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for simvastatin from Micro Labs Limited.

• FDA approval · 2020-05-21
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a Supplemental Application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP, updating the drug's labe…

• FDA approval · 2020-05-05
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Simvastatin from NorthStar Rx LLC, approving the continued marketing of this generic statin.