Aurobindo Pharma has received approval from the US Food and Drug Administration (US FDA) to manufacture and market modafinil tablets USP 100 mg and 200 mg (ANDA 202566). The product is ready for launch.
Modafinil tablets are the generic equivalent of Cephalon, Inc’s provigil tablets. Modafinil tablets USP 100 mg and 200 mg and indicated in adults for treatment of narcolepsy, shift work sleep disorders and excessive daytime sleepiness associated with obstructive sleep apnea. The product has a market size of approximately $1.2 billion for the 12 months ending March 2012 according to IMS.
The product has been approved out of unit VII (SEZ) formulations facility in Hyderabad
Aurobindo now has a total of 160 ANDA approvals (135 Final approvals including one from Aurolife Pharma LLC and 25 tentative approvals) from US FDA.
EP News Bureau
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