: Dr Reddys Laboratories Ltd Wednesday announced the launch of Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) single-dose vial, in the USA market following the approval by the US Food and Drug Administration (USFDA).
According to a press release issued by the pharma major, the drug is a therapeutic equivalent generic version of Hemabate injection, 250 mcg/mL.
"We are pleased to be first-to-market with this product that has been designated as a Competitive Generic Therapy (CGT) by the FDA. With a CGT designation, we have 180-day CGT exclusivity to market this product," Marc Kikuchi, Chief Executive Officer, North America Generics, Dr Reddys Laboratories said.
The Hemabate injection, 250 mcg/mL brand had US sales of approximately USD 55 million MAT (moving annual turnover) for the most recent twelve months ending in April 2019, Dr Reddy's said quoting market reports.
Carboprost Tromethamine is used to treat severe bleeding after childbirth (postpartum) and is also used to produce an abortion by causing uterine contractions.