Ranbaxy Laboratories said on Monday that it has received tentative approval from the US Food and Drug Administration to manufacture and market Modafinil tablets, a generic of Cepahalon's Provigil.
Sales and marketing of the product will be supported by Ranbaxy Pharmaceutical Inc, a wholly-owned subsidiary of Ranbaxy Laboratories, and will be made available to all pharmacy outlets located throughout the US after final approval is granted by USFDA, a company release said in New Delhi.
Modafinil is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.
Total market for Modafinil tablets is estimated at $297 million.