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Aurobindo Pharma Ltd has announced that it has received tentative approval from the US Food & Drug Administration for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg (base)/500mg and 15mg (base)/850mg.
The product will be eligible for final approval upon the expiration of 180-day generic drug exclusivity.
Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets in the above mentioned dosages are the generic equivalent of Takeda Global Research Development Center Inc’s Actoplus Met Tablets in same dosages.
The tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes when treatment with both pioglitazone and metformin is appropriate.
The product has a market size of approximately $ 433 million for the twelve months ending March 2012 according to IMS.
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