Content about Painkiller

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 8, 2013

Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

NEW YORK — Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

The FDA listed the guidelines on its website, saying that unused fentanyl patches should be stored out of the reach and sight of children, while used patches should be folded, sticky sides together, and flushed down the toilet.

July 2, 2013

A dramatic increase in the number of women dying from opioid painkiller overdoses has health officials alarmed.

NEW YORK — A dramatic increase in the number of women dying from opioid painkiller overdoses has health officials alarmed.

The Centers for Disease Control and Prevention announced Tuesday results of an analysis showing that nearly 48,000 women died of prescription painkiller overdoses between 1999 and 2010, with the rate of women dying this way in 2010 increasing more than five-fold during that time. The number of men who died from prescription painkiller overdoses in 2010 increased by 265% over 1999.

May 17, 2013

A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

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 25, 2013

Greenstone has launched an authorized generic painkiller, the company said.

PEAPACK, N.J. — Greenstone has launched an authorized generic painkiller, the company said.

Greenstone, the generics arm of Pfizer, announced the introduction of authorized generic oxaprozin caplets in the 600 mg strength. The drug is a version of Pfizer's Daypro, a non-steroidal anti-inflammatory drug, or NSAID.

Authorized generics are branded drugs sold under their generic names at a reduced price.

 

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.

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

February 14, 2013

Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

PARSIPPANY, N.J. — 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 companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.

January 31, 2013

A standards-development organization for the pharmacy services industry has updated a white paper on protecting consumers and patients from accidental overdoses of the painkiller acetaminophen.

SCOTTSDALE, Ariz. — A standards-development organization for the pharmacy services industry has updated a white paper on protecting consumers and patients from accidental overdoses of the painkiller acetaminophen.

The NCPDP announced the updated white paper, "NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen Version 1.1."

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.

November 20, 2012

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.

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.

September 25, 2012

Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

The drug maker announced the recall of hydrocodone bitartrate and acetaminophen tablets in the 10 mg/500 mg strengths based on a customer complaint of tablets that were thicker and darker-colored than the others.

January 27, 2012

Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

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.

October 7, 2011

Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for morphine sulfate and naltrexone hydrochloride extended-release capsules in the 30-mg/1.2-mg, 50-mg/2-mg, 60-mg/2.4-mg, 80-mg/3.2-mg and 100-mg/4-mg strengths. The drug is a generic version of Embeda, made by Pfizer subsidiary King Pharmaceuticals.

August 12, 2011

Lannett announced that it has started shipping morphine sulfate oral solution, a painkiller approved by the Food and Drug Administration in June.

PHILADELPHIA—Lannett has started shipping a painkiller product approved by the Food and Drug Administration in June, the company said.

Lannett announced the shipment of morphine sulfate oral solution. Lannett sought FDA approval using a 505(b)(2) new drug application. Sales of morphine sulfate oral solution at average wholesale price were $31.7 million during the 12-month period ending in June, according to Wolters Kluwer.

April 20, 2011

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.

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.