Content about Opana ER

September 13, 2013

Actavis has launched a generic version of an extended-release opioid painkiller, the company said.

PARSIPPANY, N.J. — Actavis has launched a generic version of an extended-release opioid painkiller, the company said.

The drug maker announced the launch of oxymorphone extended-release tablets in the 5-mg, 10-mg, 20-mg, 30-mg and 40-mg strengths. Actavis received approval for the drug in July.

The drug is a generic version of Endo's Opana ER. Endo is currently suing Actavis, alleging that Actavis' generic infringes some of its patents. The drug is used for around-the-clock pain relief.

July 17, 2013

New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

 BURLINGTON, Mass. — New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

July 15, 2013

The Food and Drug Administration has approved a generic opioid painkiller made by Actavis, the drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic opioid painkiller made by Actavis, the drug maker said.

May 30, 2013

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

May 13, 2013

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.

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.

April 16, 2013

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.

NEW YORK — 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.

January 9, 2013

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.

SILVER SPRING, Md. — 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.

December 21, 2012

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.

CHADDS FORD, Pa. — 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.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

January 9, 2012

Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

December 12, 2011

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

Endo announced the FDA's approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal's Intac technology. The new version will otherwise be identical to the old one.

June 24, 2011

The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

January 10, 2011

The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

October 6, 2010

Watson Pharmaceuticals has settled a patent lawsuit with Endo Pharmaceuticals concerning an Endo prescription painkiller,...

MORRISTOWN, N.J. Watson Pharmaceuticals has settled a patent lawsuit with Endo Pharmaceuticals concerning an Endo prescription painkiller, Watson said Thursday.

 

The generic drug maker said its subsidiary, Watson Labs, had received a royalty-free license to Endo’s patents covering the extended-release painkiller Opana ER (oxymorphone).

 

 

Watson will have the right to launch its version of the drug in September 2012. Other details of the settlement were not disclosed, Watson said.

 

May 16, 2010

The Food and Drug Administration has given tentative approval to an Impax Labs drug for...