Mallinckrodt

Drug Manufacturer Pays Settlement Over Opioid
Drug Manufacturer Pays Settlement Over OpioidMallinckrodt to pay settlement for not reporting orders or keeping accurate records.
FDA concerned about generic ADHD drugsFDA has warned about 2 approved generic versions of Concerta tablets to treat attention-deficit hyperactivity disorder (ADHD).
FDA questions effectiveness of two generic versions of ConcertaFDA recently raised concerns that two generic versions of Concerta (methylphenidate hydrochloride extended-release tablets; Janssen Pharmaceuticals) may not be therapeutically equivalent to the brand-name drug.
Investigational oral formulation of hydrocodone, acetaminophen shows efficacy in phase 3 acute pain trialAn investigational extended-release oral formulation of hydrocodone and acetaminophen the treatment of moderate to moderately severe acute pain was more effective than placebo at providing rapid and consistent pain relief in patients 48-hours post-surgery, according to a recent data presented at PAINWeek 2014 in Las Vegas.
Mallinckrodt Specialty GenericsMallinckrodt Pharmaceuticals started formulating and supplying industry-leading pharmaceutical products more than 146 years ago. Continually building on its legacy, the company employs a vertically integrated process to ensure quality control during every step of the product’s development from active ingredient processing through formulation, manufacturing, and distribution.
FDA Drug Approvals: April 2014FDA actions in brief, fast-track designation, orphan drug designation, first-time generic approvals
Xartemis XR receives FDA approval: May reduce opioid abuseOxycodone hydrochloride and acetaminophen (Xartemis XR, Mallinckrodt) Extended-Release Tablets (CII) were approved for the management of acute pain requiring opioid treatment. Xartemis XR has been specifically formulated to reduce abuse, according to the drug’s manufacturer.
February FDA drug approvalsFDA actions in brief, complete response, breakthrough therapy designation, fast-track designation