Mylan announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Pioglitazone Tablets, the generic version of Takeda’s Actos tablets. Previously, the company also received final approval from the FDA for its ANDA for Pioglitazone HCl and Metformin HCl Tablets, the generic version of Takeda’s ACTOplus met tablets.
Pioglitazone HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and as monotherapy or in combination with metformin, insulin, or a sulfonylurea. Pioglitazone/Metformin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes in patients already on pioglitazone and metformin, or when response to pioglitazone or metformin alone is inadequate.
Pioglitazone Tablets are available in 15mg, 30mg and 45mg dosage strengths, and Pioglitazone/Metformin Tablets are available in 15mg/500mg and 15mg/850mg dosage strengths.
For more information call (800) RX-MYLAN or visit www.mylan.com.