Watson seeks FDA approval for generic Welchol

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.

Watson’s application included a Paragraph IV certification, a legal assertion that the patents covering Welchol are invalid, unenforceable or not vulnerable to infringement. Under the terms of the Hatch-Waxman Act of 1984, Daiichi Sankyo and Genzyme have filed suit against Watson in the U.S. District Court for the District of Delaware, putting a stay of final Food and Drug Administration approval on the drug until June 2013, or until the companies reach a settlement.