Copaxone is a multi-billion dollar drug and a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis
Dr Reddy’s Laboratories (DRL) expects to launch the generic version of Copaxone in the US market during the first half of next fiscal. Copaxone(glatiramer acetate injection) is a multi-billion dollar drug and a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis.
“We are on track to respond to FDA on the queries received in Jan/Feb18 over next couple of months. Post that, we are likely to get new (target action date) TAD/Goal Date.” “While it is difficult to speculate the timelines for FDA review, we remain optimistic with respect to the approval / launch of this product sometime in the first half of next year,” a DRL spokesperson told PTI.
“We believe the file is progressing in the right direction. As far as the launch is concerned, we believe we have a good IP position and will evaluate based on a holistic review of the entire IP landscape,” the official said.
Suboxone is used to treat adults who are dependent on (addicted to) opioids (either prescription or illegal). On birth control device Nuvaring, the DRL official said they are optimistic of launching the product during the current fiscal. Earlier, a senior official of the city-based drug maker had said they were eyeing to launch about 16-16 new products in the US market every year.