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Aurobindo gains on USFDA final nod for anti-psychotic tablets

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Press Trust of India Mumbai
Last Updated : Oct 09 2015 | 6:02 PM IST
Shares of Aurobindo Pharma climbed 5 per cent today as the company has received final approval from the US health regulator FDA to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market.
The stock jumped 4.98 per cent to settle at Rs 787.95 on BSE. During the day, it gained 5.25 per cent to Rs 790.
On NSE, it rose 4.92 per cent to Rs 787.50.
"The company has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Aripiprazole tablets... And the product is ready for launch," Aurobindo Pharma said in a statement today.
The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg, it added.
The approved ANDA (Abbreviated New Drug Application) is for the generic version of Otsuka Pharmaceutical's Abilify tablets in the same strength, Aurobindo Pharma said.
The approved product has an estimated market size of USD 7.3 billion for 12 months ending August, the company said citing IMS estimates.

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First Published: Oct 09 2015 | 6:02 PM IST

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