FDA designate product as CGT

Dr. Reddy’s Laboratories Ltd has announced the launch of Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) Single-dose Vial, a therapeutic equivalent generic version of Hemabate® injection, 250 mcg/mL, approved by the U.S. Food and Drug Administration (USFDA).

“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, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories.

“With a CGT designation, we have 180-day CGT exclusivity to market this product,” he said announcing the product on 3 July 2019.

The Hemabate® injection, 250 mcg/mL brand had U.S. sales of approximately $55 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health*.

Dr. Reddy’s Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) contains carboprost tromethamine equivalent to 250 mcg of carboprost. fiinews.com