Complete Response Letter for Roxicodone immediate release tablets for the management of pain severe enough to require an opioid analgesic. Mallinckrodt + SpecGX LLC
SpecGx LLC, a subsidiary of Mallinckrodt plc that operates its Specialty Generics business, announced that it has received a Complete Response Letter from the FDA related to its New Drug Application (NDA) for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
In the letter, the Agency provided guidance regarding areas of further evaluation necessary to resubmit the NDA for further review and potential approval of the drug, which was designed with properties to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application MNK-812.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins