Caraco gets tentative FDA nod for generic sleep disorder drug

Fri Jul 20, 2007 2:50PM EDT

July 20 (Reuters) - Caraco Pharmaceutical Laboratories Ltd. (CPD.A: Quote, Profile, Research) said U.S. health regulators granted a tentative approval for its modafinil tablets, 100mg and 200mg, the generic version of Cephalon Inc.'s (CEPH.O: Quote, Profile, Research) sleep disorder drug Provigil.

Provigil tablets had U.S. sales of about $753 million for the 12-month period ended March 31, according to health information provider IMS Data, the company said in a statement.