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Aurobindo Pharma Receives FDA Approval to Manufacture Generic Narcolepsy Drug

by Kathy Jones on September 29, 2012 at 2:38 PM
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 Aurobindo Pharma Receives FDA Approval to Manufacture Generic Narcolepsy Drug

Indian drug maker Aurobindo Pharma revealed that it has received approval from the US Food and Drug Administration to manufacture modafinil tablets in the US.

The company said that it has received approval to manufacture the tablets in 100 mg and 200 mg strengths and added that the tablets were approved out of its Unit-VII formulations facility in Hyderabad.

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Modafinil tablets are generic versions of Provigil tablets manufactured by Cephalon Inc and are used in treating narcolepsy, shift work sleep disorders and excessive daytime sleepiness associated with obstructive sleep apnea. According to figures from IMS Health, modafinil tablets accounted for more than $1.2 billion in sales for the last 12 months ending March 2012.


Source: Medindia
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