Content about Colesevelam

August 13, 2012

In a study involving more than 16,000 U.S. children and adolescents, there has been a decrease in average total cholesterol levels over the past two decades, although almost 1-in-10 subjects had elevated total cholesterol in the 2007-2010 period, according to a study published in the Aug. 8 issue of the Journal of the American Medical Association.

CHICAGO — In a study involving more than 16,000 U.S. children and adolescents, there has been a decrease in average total cholesterol levels over the past two decades, although almost 1-in-10 subjects had elevated total cholesterol in the 2007-2010 period, according to a study published in the Aug. 8 issue of the Journal of the American Medical Association.

July 25, 2011

The Food and Drug Administration has approved a new means of administration for a drug made by Daiichi Sankyo, the drug maker said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new means of administration for a drug made by Daiichi Sankyo, the drug maker said Monday.

Daiichi Sankyo announced the FDA approval of Welchol (colesevelam hydrochloride) for oral suspension to be mixed with fruit juice or diet soft drinks. The drug, used to improve blood-sugar control and cholesterol levels in patients with Type 2 diabetes and high cholesterol, received approval in 2009 for mixing with water.

June 30, 2011

Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

HAYWARD, Calif. — Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

January 26, 2011

Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.

November 22, 2010

Impax confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the FDA for approval ...

HAYWARD, Calif. A generic drug maker confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the Food and Drug Administration for approval.

Impax said Daiichi Sankyo and Genzyme are seeking to block Impax's generic version of Welchol (colesevelam HCl) for oral suspension, in 3.75 g/packet and 1.875 g/packet strengths. The two drug makers filed suit for patent infringement against Impax in the U.S. District Court for the District of Delaware after being notified that the FDA accepted Impax's ANDA for the drug.

August 5, 2010

Biotech company Genzyme and Isis Pharmaceuticals have finished late-stage clinical trials of a cholesterol-lowering drug,...