Aurobindo Pharma Limited, a city-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received tentative approval from the US Food and Drug Administration (US FDA) for pioglitazone hydrochloride and metformin hydrocloride tablets in 15 mg (base)/500 mg and 15 mg (base)/850 mg strengths.
In a filing to the BSE on Thursday, the company said that the product will be eligible for final approval upon the expiration of 180-day generic drug exclusivity.
Pioglitazone hydrochloride and metformin hydrocloride tablets, the generic equivalent of Takeda Global Research Development Centre Inc’s Actoplus Met tablets, are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-II diabetes mellitus when treatment with both pioglitazone and metformin is appropriate.
According to IMS Health, the product has a market size of approximately $433 million for the 12 months ending March 2012. The product has been approved out of Aurobindo's Unit-VII formulations facility in Hyderabad, the company said.
Aurobindo now has 159 ANDA (abbreviated new drug application) approvals from the US FDA. Of these, 25 are tentative approvals and 134 final approvals, including one for Aurolife Pharma LLC, a wholly-owned subsidiary of Aurobindo Pharma USA Inc.
Aurobindo’s scrip is currently trading at Rs 140.55 on the BSE, up 0.11%, over the previous close of Rs 140.40.
