Content about Opioid

SILVER SPRING, Md. — 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.

NEW YORK — A dramatic jump in the rates of misuse of prescription stimulants over the past four years is linked to lax attitudes on the part of parents, according to a new study, though misuse and abuse of prescription opioids has remained flat.

BEDMINSTER, N.J. — 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.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.

The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

NEW YORK — Canada's federal government has allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

The Associated Press reported that Canadian health minister Leona Aglukkaq turned down requests from provincial and aboriginal tribal authorities to delay approval of a generic version of Purdue Pharma's OxyContin (oxycodone). OxyContin will lose its patent protection in Canada on Sunday.

RARITAN, N.J. — The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

One of the fastest-growing drug trends in the United States isn’t teenagers smoking pot or young adults on ecstasy at dance clubs, but abuse and misuse of legal prescription drugs.


TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

TARRYTOWN, N.Y. — Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

The two companies signed the agreement for Relistor (methylnaltrexone bromide), an injected drug used to treat opioid-induced constipation in patients for whom laxatives haven’t worked.

RICHMOND, Va. The Food and Drug Administration has approved Reckitt Benckiser’s treatment for opioid addiction, Reckitt Benckiser said.

The drug maker announced the approval of Suboxone (buprenorphine and naloxone), a drug delivered through a fast-dissolving film placed under the tongue. The film is based on a technology known as PharmFilm, made by MonoSol Rx.