Hyperlipidemia

• FDA approval · 2014-05-14
  FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for Lovaza (omega-3-acid ethyl esters) submitted by Waylis Therapeutics LLC.

• FDA approval · 2014-04-23
  FDA Approved: NIACIN — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' NIACIN as an original generic application for nicotinic acid, intended to treat niacin defic…

• FDA approval · 2014-04-23
  FDA Approved: NIACIN — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves NIACIN as an original-application generic from Sun Pharmaceutical Industries for the treatment of hyperlipidemia.

• FDA approval · 2014-04-21
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the combination product amlodipine besylate and atorvastatin calcium from Prasco Laboratories.

• FDA approval · 2014-03-20
  FDA Approved: NIACIN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original abbreviated new drug application for NIACIN, a generic nicotinic acid product.

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• FDA approval · 2014-03-11
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. The approval …

• FDA approval · 2014-03-07
  FDA Approved: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved the original application for a generic fixed-dose combination of amlodipine besylate and atorvastatin calcium from Dr. Reddy's …

• FDA approval · 2014-01-22
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2014-01-22
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc., indicating a…

• FDA approval · 2013-12-04
  FDA Approved: FENOFIBRIC ACID — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for fenofibric acid, a lipid-lowering agent indicated for certain lipid disorde…

• FDA approval · 2013-11-29
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves an original ANDA for AMLODIPINE AND ATORVASTATIN (Mylan Pharmaceuticals Inc.), a generic fixed-dose combination product.

• FDA approval · 2013-11-07
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for amlodipine and atorvastatin (amlodipine besylate and atorvastatin calci…

• FDA approval · 2013-10-25
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC to the existing NDA.

• FDA approval · 2013-10-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Fenofibrate submitted by Lupin Pharmaceuticals, Inc. This indicates a change or addition to …

• FDA approval · 2013-10-16
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.

• FDA approval · 2013-09-30
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin submitted by Accord Healthcare, Inc.

• FDA approval · 2013-08-06
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., authorizing a new generic version of the drug.

• FDA approval · 2013-07-31
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine and atorvastatin, with Prasco Laboratories listed a…

• FDA approval · 2013-07-26
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for lovastatin, authorizing changes requested in the application (such as l…

• FDA approval · 2013-07-26
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for fenofibrate from Mylan Pharmaceuticals Inc., approving changes to the approved generic product.

• FDA approval · 2013-07-26
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for Pravastatin Sodium submitted by Quallent.

• FDA approval · 2013-07-26
  FDA Approved: FENOFIBRATE — Original Application (Apotex Corp.)

  The FDA approves the original (ANDA) application for fenofibrate from Apotex Corp., granting generic approval for the lipid-lowering medicin…

• FDA approval · 2013-06-28
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. to update lab…

• FDA approval · 2013-06-28
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc., under NDA 022362…

• FDA approval · 2013-04-29
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin submitted by Carlsbad Technology, Inc. under ANDA 075991.