hydrocodone and acetaminophen (MNK-155) / Mallinckrodt - LARVOL DELTA

Mallinckrodt's CEO discusses F1Q2014 results - Earnings call transcript (SeekingAlpha) - Anticipated decision on NDA submission for Xartemis XR from the FDA by end of this month; Anticipated NDA filing during H2 2014 for MNK-155; Anticipated generic launch for Exalgo 32 milligram dosage strength in May.

Anticipated generic launch • Anticipated NDA • Pain

The FDA is pushing for greater restrictions on prescription painkillers: Now what (PR Web) - "According to George Catlin of Withdrawal Ease, the FDA's new restrictions on painkillers are not without risk...If these recommendations are approved by the DEA, the new regulations to go into effect in 2014."

Anticipated regulatory • Pain

A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain (clinicaltrials.gov) - P3; N=99; Terminated; Sponsor: Neil Singla; Recruiting ➔ Terminated; Trial primary completion date: May 2015 ➔ Dec 2015

Trial primary completion date • Trial termination • Biosimilar • Pain