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DETROIT, July 20 (UPI) -- Caraco Pharmaceutical Laboratories said Friday it has been granted tentative U.S. approval to market a generic version of Cephalon's Provigil.
The company said the Food and Drug Administration has granted tentative approval to its modafinil tablets in 100-mg and 200-mg strengths, indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy.
Caraco said Provigil tablets had U.S. sales of roughly $753 million for the 12-month period ending March 31, based on IMS data.
"We are extremely pleased to receive this tentative approval," said Daniel Movens, Caraco's CEO. "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."
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