A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.
A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.
The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.
Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.
The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.
The Consumer Healthcare Products Association’s Stop Medicine Abuse campaign was selected as an official honoree in the 17th Annual Webby Awards in the Family/Parenting category, the over-the-counter association announced.
Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.
The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.
The National Community Pharmacists Association called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.
Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults.
The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.
The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.
Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.
The National Community Pharmacists Association submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.
Men taking long-acting medications for chronic pain are almost five times more likely to have low testosterone levels, according to a new study by Kaiser Permanente.
One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.
The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors, 3% of eighth graders and 4.7% of tenth graders abused over-the-counter cough and cold medicines containing dextromethorphan, bringing the overall average to under 5%.
A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.
Canadian regulators have allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.