Purdue Pharma expects the FDA to vote yea or nay on the drug by October.
The Centers of Disease Control reports that prescribers wrote enough painkiller prescriptions to give one bottle to every adult in the US in 2012.
A USA today analysis shows Medicare painkiller prescriptions rose 30% between 2007 and 2012.
The regulator defends its approval decision in a web post.
A District Court says Massachusetts cannot ban opioid painkiller Zohydro.
The Bay State is saying no to the controversial prescription painkiller.
West Virginia's Joe Manchin has sponsored a bill to push pain medication Zohydro off the FDA's approval list.
A study says that more opioid abusers get their medications via prescription than they do second-hand.
A group called the FED up! Coalition has sent a letter to FDA Commissioner Margaret Hamburg, urging her to overturn the approval.
Purdue Pharma says it will appeal.
State legal reps ask Commissioner Hamburg to overturn the approval.
inVentiv launches new policy shop; early test shows Novo's Victoza may have Alzheimer's future; Bayer joins the list of China's scrutinized pharma companies; a Chicago bar gives Purdue unwanted attention
The changes, which include tightening prescribing criteria of extended-release and long-acting opioids and a boxed warning for pregnancy, are part of an effort to curb abuse. Some said the FDA's effort is too limited
Phase II studies found recreational abusers were not significantly bothered by the mechanism meant to make a "deterrent" version unpleasant to snort.
The drugstore chain says it has cut off over-prescribers of tightly controlled medications.
HHS is looking into how J&J marketed opioid painkiller Nucynta, adding to the firm's list of investigations and those of the industry as a whole.
The drug maker can now add five new doses to its generic Opana ER offerings.
India bans sales of Takeda's Actos; Takeda make a $10-million milestone payment to Sucampo; and Pfizer Consumer Care says Advil is the official pain reliever of Tough Mudder.
Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status.