Fenofibrate News and Research

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Fenofibrate is a drug used to treat high levels of cholesterol and triglycerides in the blood. Fenofibrate is being studied in the treatment of advanced cancers in young patients and in the treatment of other conditions. It is a type of antilipidemic agent. Also called Lofibra and TriCor.

Promising new therapeutic strategy for chronic kidney disease

Chronic kidney disease (CKD) affects at least one in four Americans who are older than 60 and can significantly shorten lifespan. Yet the few available drugs for CKD can only modestly delay the disease's progress towards kidney failure. Now, however, a team led by researchers at the Perelman School of Medicine at the University of Pennsylvania, has found an aspect of CKD's development that points to a promising new therapeutic strategy.

1 Dec 2014

Ranbaxy obtains FDA approval to manufacture, market Fenofibrate Capsules USP, 43 mg and 130 mg

Ranbaxy Laboratories Limited announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively, of Lupin Atlantis.

5 Nov 2014

Epicure project: an interview with Frédéric Cren

Epicure is a project led by Inventiva and Institut Curie that aims to deliver pre-clinical candidates on two novel epigenetic targets that have been selected due to their potential to activate immune responses against cancer cells. In addition one of these two targets has potential in respiratory indications such as asthma or COPD.

3 Nov 2014

Salix Pharmaceuticals' total net product revenue increases 90% to $384.4 million in Q1 2014

Salix Pharmaceuticals, Ltd. today announced financial and operating results for the first quarter ended March 31, 2014, and other business updates.

9 May 2014

Impax Laboratories records adjusted net loss of $1.6 million in fourth quarter 2013

Impax Laboratories, Inc. today reported fourth quarter and full year ended December 31, 2013 results.

21 Feb 2014

FDA issues final approval for Lupin's sNDA for Antara capsules

Pharma Major Lupin Limited announced today that it has received final approval for its supplemental New Drug Application for Antara (Fenofibrate) capsules, 30 mg & 90 mg strengths from the United States Food and Drug Administration.

23 Oct 2013

Par Pharmaceutical receives final ANDA approval for generic version of Trilipix

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid EQ 45 mg and EQ 135 mg delayed-release capsules.

19 Jul 2013

Santarus, Pharming Group announce FDA acceptance of RUCONEST BLA

Santarus, Inc. and Pharming Group NV today announced that the U.S. Food and Drug Administration has accepted for filing the Biologics License Application for the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 IU/kg.

18 Jun 2013

FDA approves Mylan's ANDA for Fenofibrate Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg.

17 May 2013

Merck's LIPTRUZET tablets get FDA approval for treatment of elevated LDL cholesterol

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved LIPTRUZET (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

4 May 2013

Santarus, Pharming Group submit Biologics License Application to FDA for RUCONEST

Santarus, Inc. and Pharming Group NV today announced the submission of a Biologics License Application to the U.S. Food and Drug Administration to obtain marketing approval for RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema.

17 Apr 2013

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today the U.S. commercial launch of UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

14 Feb 2013

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

16 Jan 2013

Lupin’s Fenofibrate tablets now available in the U.S.

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has launched its Fenofibrate Tablets, 48 mg and 145 mg strengths in the United States. Lupin had earlier received final approval for the same from the US Food and Drug Administration (FDA).

21 Nov 2012

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Santarus, Inc. and Pharming Group NV today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

7 Nov 2012

Health benefits of fibrate add-on detected postprandially

Adding fenofibrate to statin treatment significantly improves postprandial triglyceride response over statin treatment alone in individuals with diabetes, show findings from a US study.

18 Oct 2012

Health benefits of fibrate add-on detected postprandially

Adding fenofibrate to statin treatment significantly improves postprandial triglyceride response over statin treatment alone in individuals with diabetes, show findings from a US study.

18 Oct 2012

Positive results from Santarus rifamycin SV MMX Phase III study on travelers' diarrhea

Santarus, Inc. today announced that its Phase III clinical study to evaluate the safety and efficacy of the investigational drug, rifamycin SV MMX, met the primary endpoint of reducing time to last unformed stool (TLUS) in patients with travelers' diarrhea.

12 Sep 2012

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Santarus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013.

14 Aug 2012

FDA approves Cipher’s Absorica to treat severe recalcitrant nodular acne

Cipher Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica, Cipher's novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne.

28 May 2012

Fenofibrate News and Research

Promising new therapeutic strategy for chronic kidney disease

Ranbaxy obtains FDA approval to manufacture, market Fenofibrate Capsules USP, 43 mg and 130 mg

Epicure project: an interview with Frédéric Cren

Salix Pharmaceuticals' total net product revenue increases 90% to $384.4 million in Q1 2014

Impax Laboratories records adjusted net loss of $1.6 million in fourth quarter 2013

FDA issues final approval for Lupin's sNDA for Antara capsules

Par Pharmaceutical receives final ANDA approval for generic version of Trilipix

Santarus, Pharming Group announce FDA acceptance of RUCONEST BLA

FDA approves Mylan's ANDA for Fenofibrate Tablets

Merck's LIPTRUZET tablets get FDA approval for treatment of elevated LDL cholesterol

Santarus, Pharming Group submit Biologics License Application to FDA for RUCONEST

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

Lupin’s Fenofibrate tablets now available in the U.S.

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Health benefits of fibrate add-on detected postprandially

Health benefits of fibrate add-on detected postprandially

Positive results from Santarus rifamycin SV MMX Phase III study on travelers' diarrhea

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

FDA approves Cipher’s Absorica to treat severe recalcitrant nodular acne

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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