Aurobindo Pharma has received an approval from the US Food and Drug Administration (USFDA) to manufacture and market Modafinil Tablets USP 100mg and 200mg (ANDA 202566). The product is ready for launch. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.
Modafinil Tablets are the generic equivalent of Cephalon, Inc’s Provigil Tablets. Modafinil Tablets USP 100mg and 200mg are indicated in adults for treatment of narcolepsy, shift work sleep disorders and excessive daytime sleepiness associated with obstructive sleep apnea. According to IMS for the twelve months ending March 2012, the product has a market size of approximately $1.2 billion.
Aurobindo now has a total of 160 ANDA approvals (135 Final approvals including 1 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.
