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March 26, 2013
FDA approves Actavis drug for opioid dependence

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 ships opioid-dependence drug

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
FDA approves Amneal opioid-dependence drug

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
FDA approves opioid addiction treatment

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
FDA approves Reckitt Benckiser's Suboxone

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.