Content about Naloxone

April 3, 2014

The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. 

March 28, 2014

Pharmacists in New Mexico have become the first in the United States certified to prescribe Narcan (naloxone), which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension, according to a report published Wednesday by The New Mexican.

SANTA FE, N.M. — Pharmacists in New Mexico have become the first in the United States certified to prescribe Narcan (naloxone), which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension, according to a report published Wednesday by The New Mexican

January 23, 2014

Assembly Member Richard Bloom, D-Santa Monica, introduced legislation that would authorize a pharmacist to dispense the narcotic antagonist naloxone hydrochloride without a prescription in California.

SACRAMENTO, Calif. — Assembly Member Richard Bloom, D-Santa Monica, on Tuesday introduced legislation that would authorize a pharmacist to dispense the narcotic antagonist naloxone hydrochloride without a prescription in California. 

Naloxone is used to treat overdoses of narcotic medications including morphine, codeine and oxycodone and works by reversing the side effects of the narcotic, such as sedation and decreased breathing rate.

November 26, 2013

The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

The drug maker announced the FDA's acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.

October 15, 2013

Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

September 16, 2013

A drug for treating opioid dependence has been launched, the manufacturer said Monday.

NEW YORK — A drug for treating opioid dependence has been launched, the manufacturer said Monday.

Orexo announced the introduction of Zubsolv (buprenorphine; naloxone) sublingual tablets for the maintenance treatment of opioid dependence. The drug is designed for use as part of a broader treatment regimen that combines drug therapy and counseling.

July 9, 2013

The Food and Drug Administration has approved a new drug for treating opioid dependence.

NEW YORK — The Food and Drug Administration has approved a new drug for treating opioid dependence.

Orexo U.S. announced the approval of Zubsolv (buprenorphine; naloxone) sublingual tablets. The drug, Schedule III controlled substance, is approved for use once per day in the maintenance treatment of opioid dependence. Opioid dependence affects nearly 5 million people in the United States, according to the Substance Abuse and Mental Health Services Administration, but about 60% of those affected don't receive treatment.

June 11, 2013

Misperceptions and stereotypes about opioid dependence that may affect how it's treated have persisted among the general public and physicians despite increased attention devoted to the issue, according to a new survey.

RICHMOND, Va. — Misperceptions and stereotypes about opioid dependence that may affect how it's treated have persisted among the general public and physicians, despite increased attention devoted to the issue, according to a new survey.

March 26, 2013

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

 

March 5, 2013

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

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.

February 25, 2013

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

 

August 21, 2012

The Food and Drug Administration has approved a drug made by Reckitt Benckiser Pharmaceuticals for treating addiction to opioid drugs, the drug maker said.

RICHMOND, Va. — The Food and Drug Administration has approved a drug made by Reckitt Benckiser Pharmaceuticals for treating addiction to opioid drugs, the drug maker said.

Reckitt Benckiser announced the approval of Suboxone (buprenorphine and naloxone) sublingual film in the 4 mg and 12 mg strengths, used for the maintenance treatment of dependence on prescription opioid painkillers and heroin. Addiction to opioid drugs is a growing epidemic in the United States, the company said.

September 1, 2010

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

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.