Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-08-17FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)
FDA supplemental approval for a rosuvastatin calcium product from Glenmark Pharmaceuticals Inc. USA.
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FDA approval · 2026-08-17FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA supplemental application approval for Camber Pharmaceuticals' rosuvastatin product.
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FDA approval · 2026-08-04FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)
Supplemental approval for fenofibrate from Bostal LLC.
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FDA approval · 2026-07-31FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
Supplemental approval for rosuvastatin calcium by Rising Pharma Holdings, Inc..
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FDA approval · 2026-03-11FDA Approved: FENOFIBRIC ACID — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for Fenofibric acid by Alembic Pharmaceuticals Limited.
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FDA approval · 2026-03-05FDA Approved: CHOLESTYRAMINE — Original Application (Micro Labs Limited)
FDA approves Micro Labs Limited's original application for CHOLESTYRAMINE, a generic bile acid sequestrant used to lower cholesterol in pati…
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FDA approval · 2026-01-21FDA Approved: FENOFIBRATE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's fenofibrate under an Original Application (ANDA 210379). The approval permits the generic fe…
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FDA approval · 2025-10-01FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Fenofibrate submitted by Lupin Pharmaceuticals, Inc., indicating a regulatory change to this…
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FDA approval · 2025-08-28FDA Approved: FENOFIBRATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for fenofibrate, authorizing continued marketing of fenofibrate for lipid-…
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FDA approval · 2025-08-21FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)
FDA approved a supplemental application for Fenofibrate by AvKARE. This approval supports the generic product's marketing under an approved …
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FDA approval · 2025-08-21FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for fenofibrate filed by Cipla USA Inc. under the ANDA 208709.
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FDA approval · 2025-08-21FDA Approved: FENOFIBRATE — Supplemental Application (Creekwood Pharmaceuticals LLC)
FDA approved a supplemental application for fenofibrate submitted by Creekwood Pharmaceuticals LLC. The action represents an approved regula…
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FDA approval · 2025-08-05FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s supplemental application for pravastatin sodium, authorizing continued marketing of the product as a stati…
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FDA approval · 2025-06-26FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited. This pertains to a generic pravastatin…
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FDA approval · 2025-06-13FDA Approved: PITAVASTATIN — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a supplemental application for pitavastatin calcium by Teva Pharmaceuticals, updating/expanding the existing approval for this …
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FDA approval · 2025-06-06FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved the supplemental application for Lipofen (fenofibrate) submitted by ANI Pharmaceuticals, Inc., granting regulatory approval…
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FDA approval · 2025-06-06FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approves a supplemental application for fenofibric acid submitted by Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2025-05-23FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Apotex Corp.)
FDA approved a supplemental abbreviated new drug application (ANDA) for Apotex Corp. to market a generic fixed-dose combination of amlodipin…
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FDA approval · 2025-05-22FDA Approved: FENOFIBRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for fenofibrate (generic) under ANDA 201748, authorizing the mar…
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FDA approval · 2025-05-22FDA Approved: AMLODIPINE AND ATORVASTATIN — Original Application (Alembic Pharmaceuticals Inc.)
FDA approves Alembic Pharmaceuticals' fixed-dose combination of amlodipine and atorvastatin under an original ANDA application.
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FDA approval · 2025-04-22FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Colesevelam hydrochloride (generic) submitted by Bionpharma Inc., effectively granting approval …
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FDA approval · 2025-04-10FDA Approved: NIACIN — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA has approved a supplemental application for NIACIN submitted by Macleods Pharmaceuticals Limited.
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FDA approval · 2025-04-10FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
The FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, granting approva…
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FDA approval · 2025-03-18FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium by Aurobindo Pharma Limited.
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FDA approval · 2025-03-18FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)
FDA approved a supplemental application for pravastatin sodium from Cipla USA Inc., authorizing changes to the existing generic product.