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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has submitted abbreviated new drug application (ANDA) to market Colesevelam HCI powder for oral suspension, 1.875gm/packet and 3.75gm/packet with the US Food and Drug Administration (FDA).
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Watson claims that its Colesevelam HCI powder for oral suspension is a generic version of Daiichi Sankyo’s Welchol oral suspension.
Colesevelam is indicatred for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutarylcoenzyme A (HMG CoA) reductase inhibitor (statin), Welchol oral suspension.
It is also indicated for the reduction of LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy; and to improve glycemic control in adults with type 2 diabetes mellitus.
Recently, Daiichi and Genzyme have filed a lawsuit against Watson in the US District Court for the District of Delaware seeking to prevent Watson from commercializing Colesevelam prior to the expiration of US Patent No. 5,693,675.