Aurobindo Pharma gets US nod for sleep disorder drug

New Delhi: Aurobindo Pharma today said it received approval from the US health regulator to make and market Modafinil tablets used for treating excessive sleepiness disorder in adults the American market.

“The company has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Modafinil tablets USP 100mg and 200mg,” Aurobindo Pharma said in a statement.[caption id=“attachment_472480” align=“alignleft” width=“380”]  New medicines. Reuters[/caption]

The product is generic equivalent of Cephalon Inc’s Provigil tablets and is ready for launch, it added.

Quoting IMS Health data the company said that the product has a market size of nearly $1.2 billion for the twelve months ending March 2012.

“Modafinil tablets USP are indicated in adults for treatment of narcolepsy, shift work sleep disorders and excessive daytime sleepiness associated with obstructive sleep apnea,” it added.

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The company has 160 abbreviated new drug application (ANDA) approvals (135 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA, Aurobindo Pharma said.

Aurobindo Pharma scrip was trading at Rs 139.50 in the afternoon trade on BSE, down 0.92 percent from its previous close.