Watson confirmed today that the FDA has been ordered to approve Pioglitazone HCl Tablets, the generic version of Takeda‘s Actos. On August 15, 2012, Watson announced that it had filed suit against the FDA challenging the Agency’s decision regarding Watson’s entitlement to shared exclusivity for its generic version of Actos.
Actos, a thiazolidinedione, is indicated as an adjunct to diet and exercise in type 2 diabetes, as monotherapy or in combination with metformin, insulin, or a sulfonylurea.
Watson’s Pioglitazone Tablets will be available in 15mg, 30mg, and 45mg dosage strengths. Watson plans to ship the product immediately upon receipt of final FDA approval.
For more information call (800) 272-5525 or visit www.watson.com.