Drug news
Remoxy ER is re-submitted to FDA as an abuse-deterrent to treat severe pain.- Pain Therapeutics Inc.
Remoxy ER has a thick, sticky, high-viscosity capsule formulation designed to deter unapproved routes of drug administration, such as injection, snorting or smoking. The Remoxy NDA was filed through the 505(b)(2) regulatory pathway. Pain Therapeutics expects to be notified by FDA of a Prescription Drug User Fee Act (PDUFA) date within 60 days.