Caraco Pharmaceutical Laboratories, Ltd., has announced that the FDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Modafinil Tablets (modafinil), 100mg and 200mg. Modafinil is indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy. This new product is the bioequivalent to Provigil®, a registered trademark of Cephalon, Inc. Provigil® tablets had U.S. sales of approximately $753 million for the 12-month period ended March 31, 2007, according to IMS Data. Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are extremely pleased to receive this tentative approval. Modafinil was filed with a paragraph IV certification that we do not infringe and or that the Cephalon patent is invalid. We were not sued by Cephalon. We looked forward to marketing this product subsequent to the expiration of the patent and exclusivity period.” Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.
