Dr. Reddy’s Laboratories on Wednesday announced launch of Carboprost Tromethamine injection USP 250 mcg/ml (1 ml) single-dose vial, a therapeutic equivalent generic version of Pfizer’s Hemabate injection. “We are pleased to be first-to-market with this product that has been designated as a competitive generic therapy (CGT) by the FDA,” said Marc Kikuchi, CEO, North America Generics. A 180-day CGT exclusivity to market this product is available, he said.
The Hemabate injection brand had U.S. sales of around $ 55 million MAT for the 12 months ended April 2019, Dr. Reddy’s said citing IQVIA Health. The product is indicated for treatment of postpartum hemorrhage and aborting pregnancy. The generic version is being launched with the approval of U.S. Food and Drug Administration, a release from the company said.