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Aurobindo Gets FDA Nod For Generic Equivalents Of Actos And Actoplus Met Tablets

Aurobindo Pharma Ltd. announced the receiving of final approvals from the US FDA to manufacture and market Pioglitazone tablets USP 15mg, 30mg and 45 mg covered under ANDA 200268 and its earlier tentatively approved Pioglitazone Hydrochloride + Metformin Hydrochloride tablets, 15mg(base)/500mg and 15mg(base)/850mg covered under ANDA 200823.

The company said the products were ready for launch.

Pioglitazone tablets USP 15mg, 30mg, 45 mg and Pioglitazone Hydrochloride + Metformin Hydrochloride tablets, 15mg(base)/500mg, 15mg(base)/850mg are the generic equivalents of Takeda Global Research Development Center Inc.'s Actos tablets 15mg, 30mg, 45 mg and Actoplus Met tablets, 15mg(base)/500mg, 15mg(base)/850mg, respectively.

The products are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

The combined market size of the products is around $2.8 billion for the twelve months ended September 2012, as per IMS data.

At the BSE, Aurobindo Pharma shares are currently trading at Rs.179.25, down 1.02 percent from the previous close.

by RTT Staff Writer

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