Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-01-03FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)
FDA approved a supplemental application for REPATHA (evolocumab) submitted by Amgen USA Inc.
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FDA approval · 2016-11-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for pravastatin sodium from Aurobindo Pharma Limited (ANDA077793), authorizing continued marketing o…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for rosuvastatin as a generic product. Rosuvastatin is used to treat hyperlipidemia an…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approved an Original Application for rosuvastatin calcium from Torrent Pharmaceuticals Limited, granting generic approval for the rosuva…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves rosuvastatin (generic) under an Original Application by Camber Pharmaceuticals, adding a generic statin option for lowering cho…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved an original ANDA for rosuvastatin calcium, enabling a generic version of rosuvastatin calcium manufactured by Puracap Laborator…
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FDA approval · 2016-05-19FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s atorvastatin calcium tablet as an Original Application, enabling a generic atorvastatin calcium product to…
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FDA approval · 2016-05-05FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). This confirms an approved modification to the gene…
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FDA approval · 2016-02-24FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, authorizing the generic atorvastatin…
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FDA approval · 2016-01-27FDA Approved: FLUVASTATIN SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's generic fluvastatin sodium as an original ANDA, enabling its use to treat hyperlipidemia and reduce cardiovascular risk.
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FDA approval · 2015-10-06FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)
The FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., granting regulatory approval f…
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FDA approval · 2015-06-26FDA Approved: EZETIMIBE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved the original application for ezetimibe (generic) by Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2015-06-01FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2015-04-28FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for atorvastatin calcium (Quallent).
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FDA approval · 2015-04-15FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium submitted by Aurobindo Pharma Limited, approving this generic statin product.
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FDA approval · 2014-11-25FDA Approved: SIMVASTATIN — Original Application (XLCare Pharmaceuticals Inc.)
The FDA approved the original application for SIMVASTATIN from XLCare Pharmaceuticals Inc., granting marketing authorization for a generic s…
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FDA approval · 2014-11-05FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (generic statin).
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FDA approval · 2014-11-05FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, updating the approved generic product.
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FDA approval · 2014-11-04FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for simvastatin by Micro Labs Limited under ANDA090383, updating the regulatory status of the approv…
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FDA approval · 2014-11-04FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, confirming approval of a generic ato…
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FDA approval · 2014-11-03FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited.
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FDA approval · 2014-09-30FDA Approved: ZETIA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZETIA (ezetimibe) submitted by Organon LLC. The approval updates the product labeling to reflect…
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FDA approval · 2014-09-23FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium by Mylan Pharmaceuticals, confirming the approval of a generic version of t…
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FDA approval · 2013-04-18FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Pravastatin Sodium from Lupin Pharmaceuticals (ANDA 077917), formalizing approval of this generi…
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FDA approval · 2013-03-26FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Fluvastatin Sodium (generic Fluvastatin) from Mylan Pharmaceuticals Inc. (ANDA 090595), enabling…