King Pharmaceuticals and Pain Therapeutics have announced that on July 2, 2009, King met with the FDA to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY.
The outcome of this meeting provided King Pharmaceuticals with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter.
King Pharmaceutical now anticipates the resubmission of the NDA could occur mid-year 2010. The company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required.
King Pharmaceuticals to the development and commercialization of REMOXY, and looks forward to working closely with the FDA toward approval of the product, said the company.