FDA to Review Abuse-Deterrent Oxycodone Capsule In June, the FDA will discuss the New Drug Application for Remoxy ER at an Advisory Committee meeting. Remoxy ER is a 12-hour, abuse-deterrent, extended-release oxycodone in a capsule formulation.1 The capsule contains a sticky, thick, high-viscosity formulation to deter unapproved drug administration routes, including injection, smoking or snorting….
(Reuters)—Mallinckrodt Plc., one of the largest manufacturers of the generic opioid painkiller oxycodone, will pay $35 million to resolve allegations that it failed to report suspicious drug orders, the U.S. Justice Department said on Tuesday. The deal, in which Mallinckrodt did not admit wrongdoing, marked a record settlement of claims that a drugmaker failed to properly…
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
(Reuters)—A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Privately owned, Connecticut-based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food…
Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.