Aurobindo Pharma has received approval from the US Food and Drug Administration to market anti-diabetes drug Pioglitazone tablets in the American market.

The company has received approval from the USFDA to manufacture and market Pioglitazone tablets and its earlier tentatively approved combination of Pioglitazone Hydrochloride and Metformin Hydrochloride tablets, Aurobindo Pharma said in a statement today.

The products are ready for launch, it added.

The medicines are indicated as an addition to diet and exercise to improve glycemic control in adults with Type-2 diabetes mellitus.

“The combined market size of the products is approximately $2.8 billion for the 12 months ended September 30, 2012, according to IMS,” the company said.

Aurobindo now has a total of 177 ANDA approvals (152 final approvals including two from Aurolife Pharma LLC and 25 tentative approvals) from USFDA, according to the release.

Shares of Aurobindo were trading at Rs 183.35 on the BSE, up 1.24 per cent in the afternoon trade on the BSE.

(This article was published on February 14, 2013)
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