FDA issues complete response letter to NDA for Mallinckrodt pain therapy

The SpecGx LLC subsidiary of Mallinckrodt plc (NYSE:MNK) said FDA issued a complete response letter to an NDA for Roxicodone, an immediate-release oral formulation of oxycodone hydrochloride. The company is seeking approval of Roxicodone as management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The CRL comes about a month after FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10-7 to approve Roxicodone...