Content about Oxymorphone

October 29, 2013

Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.

DUBLIN — Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.

Profits for the quarter were $65.5 million, down from $76.7 million in third quarter 2012. The quarter's results exclude figures from Ireland-based Warner Chilcott, which Actavis acquired at the beginning of the month.

October 25, 2013

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it's the people who are using it properly and legally who will end up losing.

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

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.

September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

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 8, 2013

Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

Teva announced the introduction of oxymorphone hydrochloride tablets.

The drug is a generic version of Endo Pharmaceuticals' Opana and will be available in the 5 mg and 10 mg strengths in bottles of 100 tablets.

 

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.

June 12, 2012

The Healthcare Distribution Management Association on Tuesday honored 10 pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Management Awards for Notable Achievements in Healthcare, or DIANA. The winners were announced Monday evening at the Association’s 2012 Business and Leadership Conference in San Antonio, Texas.

ARLINGTON, Va. — The Healthcare Distribution Management Association on Tuesday honored 10 pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Management Awards for Notable Achievements in Healthcare, or DIANA. The winners were announced Monday evening at the Association’s 2012 Business and Leadership Conference in San Antonio, Texas.

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.

August 9, 2011

Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

CHADDS FORD, Pa. — Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

Sales for the quarter were $607.5 million, compared with $396.5 million in second quarter 2010. Sales of branded drugs were $398.3 million, an 8% increase over last year, which the company attributed to better sales of the pain drug Opana ER and the joint pain drug Voltaren Gel.

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.

November 1, 2010

Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted....

CHADDS FORD, Pa. Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted.

Net income reached $54.2 million, compared with $49.4 million during the period ended Sept. 30. Net sales jumped 23% to $444.1 million, versus $361 million during the same period a year ago. Analysts had estimated sales of $443.36 million for the quarter.

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.

 

September 21, 2010

The Food and Drug Administration has granted priority review to an opioid painkiller designed to...

CHADDS FORD, Pa. The Food and Drug Administration has granted priority review to an opioid painkiller designed to thwart drug abusers.

 

Endo Pharmaceuticals said Wednesday that the FDA would expedite review of its new oral formulation of long-acting oxymorphone, which is designed to be crush-resistant. The FDA expects to take action on the drug in early January.

 

 

August 8, 2010

Endo Pharmaceuticals will acquire Penwest Pharmaceuticals for $168 million, Penwest said Monday....

June 7, 2010

Endo Pharmaceuticals and Penwest Pharmaceuticals will grant Impax Labs a special license to sell a...

May 16, 2010

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

March 8, 2010

Watson Pharmaceuticals has filed a regulatory approval application for a generic version of a painkiller...

February 22, 2010

Endo Pharmaceuticals saw profits of $334.3 million in 2009, a 9% increase over 2008’s $305.7...