Sunovion receives CRL for its Parkinson’s NDA 04-Feb-2019 By Maggie Lynch FDA issues Sunovion a complete response letter in regard to its NDA for its Parkinson’s disease treatment.
Court grants restraining order as Suboxone litigations continue 29-Jan-2019 By Maggie Lynch Patent litigations over Suboxone generics continue as US District Court grants restraining order against Alvogen.
Aquestive receives CRL, switches API supplier over concerning ‘quality controls’ 29-Nov-2018 By Ben Hargreaves Aquestive’s NDA to the US FDA was knocked back over API issues, but the company still expects the product to be available by 2020.