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Aurobindo Pharma Ltd has received approval from the US Food & Drug Administration to manufacture and market Modafinil tablets of 100mg and 200mg.
The product is ready for launch. Modafinil tablets in the above dosages are the generic equivalent of Cephalon Inc’s Provigil tablets, according to a press release.
Modafinil tablets are 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 twelve months ended March 2012, according to IMS.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.
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