Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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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 · 2026-08-05FDA Approved: SIMVASTATIN — Supplemental Application (WATSON LABS TEVA)
A supplemental application approval for simvastatin by Watson Labs Teva, indicating a formulation/label change under an ANDA submission.
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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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EMA approval · 2026-07-09EMA Authorised: Evkeeza (Evinacumab) — Ultragenyx Germany GmbH
EMA authorised Evkeeza (evinacumab) for hypercholesterolemia under Ultragenyx Germany GmbH, decision dated 08/07/2026.
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EMA approval · 2026-06-25EMA Authorised: Lojuxta (Lomitapide) — Chiesi Farmaceutici SpA
LOJUJTA (lomitapide) has been authorised in the EU for hypercholesterolemia by Chiesi Farmaceutici, marking an approval decision.
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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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EMA approval · 2026-03-04EMA Authorised: Leqvio (inclisiran) — Novartis Europharm Limited
The European Medicines Agency authorised Leqvio (inclisiran) from Novartis Europharm Limited for hypercholesterolemia and dyslipidemias, wit…
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EMA approval · 2026-02-27EMA Authorised: Nilemdo (bempedoic acid) — Daiichi Sankyo Europe GmbH
The European Medicines Agency authorised Nilemdo (bempedoic acid) for hypercholesterolemia and related dyslipidemias. The marketing authoris…
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EMA approval · 2026-02-27EMA Authorised: Nustendi (bempedoic acid;ezetimibe) — Daiichi Sankyo Europe GmbH
The EMA has authorised Nustendi, a fixed-dose combination of bempedoic acid and ezetimibe, for hypercholesterolemia and related dyslipidemia…
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EMA approval · 2025-12-15EMA Authorised: Repatha (Evolocumab) — Amgen Europe B.V.
EU regulators authorised Repatha (evolocumab) for dyslipidemias and hypercholesterolemia; decision date 12/12/2025.
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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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EMA approval · 2025-06-03EMA Authorised: Cholestagel (colesevelam (as hydrochloride)) — CHEPLAPHARM Arzneimittel GmbH
The EMA authorised Cholestagel (colesevelam as hydrochloride) for hypercholesterolemia, with CHEPLAPHARM Arzneimittel GmbH as the marketing …
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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 · 2025-03-12FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for rosuvastatin (generic rosuvastatin), authorizing its marketing in the Unit…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for rosuvastatin calcium submitted by Sun Pharmaceutical Industries, Inc., approving an additional f…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for rosuvastatin submitted by ScieGen Pharmaceuticals, enabling the marketing of a generic rosuv…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Rosuvastatin Calcium from Ascend Laboratories, LLC, supporting the continued availability of a r…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Umedica Laboratories USA Inc.)
The FDA granted supplemental approval for rosuvastatin calcium under an ANDA for Umedica Laboratories USA Inc., confirming the generic produ…
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FDA approval · 2025-01-10FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s supplemental application for atorvastatin calcium, authorizing its continued marketing as a generic statin…
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FDA approval · 2024-12-26FDA Approved: CHOLESTYRAMINE — Supplemental Application (EPIC PHARMA, LLC)
FDA approved a supplemental application for cholestyramine from EPIC PHARMA, LLC.
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FDA approval · 2024-12-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for a generic rosuvastatin calcium product from Quallent Pharmaceuticals Health LLC under ANDA20…
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FDA approval · 2024-12-05FDA 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…
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FDA approval · 2024-12-03FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved an Abbreviated New Drug Application for Colestipol hydrochloride by Ingenus Pharmaceuticals, LLC, establishing a generic versio…
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FDA approval · 2024-11-27FDA Approved: SIMVASTATIN — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals' original application for a generic simvastatin product, adding another generic option for choleste…
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FDA approval · 2024-11-21FDA Approved: CHOLESTYRAMINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals' original application for cholestyramine, a bile acid sequestrant, for lowering cholesterol in hyperch…