Mumbai, Jul 3: Pharma major Dr Reddy's Laboratories Ltd on Wednesday 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 US 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,' says 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.'
The Hemabate injection, 250 mcg/mL brand had US sales of approximately USD55 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. (UNI)