Content about Benzodiazepines

August 13, 2013

Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the Food and Drug Administration.

DEERFIELD, Ill. — Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the U.S. Food and Drug Administration. Onfi is a prescription medication originally approved by the FDA in 2011, and is used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 2 years of age or older. Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine.

July 18, 2012

Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

PITTSBURGH — Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

The generic drug maker said that under the settlement, it would have the right to sell doxepin hydrochloride tablets in the 3-mg and 6-mg strengths starting in January 2020. The drug is a generic version of Somaxon's Silenor.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

Merck expects to file a new drug application to the Food and Drug Administration in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

November 23, 2011

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

October 4, 2011

Mylan must pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

NEW YORK — Mylan may have to pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

Bloomberg reported that the Supreme Court rejected the drug maker's appeal of a 2005 jury verdict in a case that involved antitrust allegations regarding the drugs lorazepam and clorazepate.

February 4, 2011

Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

ECR announced Friday the launch of Zolpimist (zolpidem tartrate) oral spray. The drug comes in units that provide 60 metered sprays, administering 5-mg or 10-mg doses of the active ingredient. As a hypnotic agent, the drug is classified as a CIV controlled substance by the federal government.

September 6, 2010

Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company...

SAN DIEGO Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company said Tuesday.

 

Somaxon announced the availability of Silenor (doxepin), which received approval from the Food and Drug Administration in March as a treatment for insomnia characterized by difficulty with sleep maintenance.

 

 

June 15, 2010

The Food and Drug Administration has approved a generic drug for anxiety disorder made by...

May 25, 2010

Mylan has launched a generic short-term treatment for insomnia, the generic drug maker said Tuesday....

March 17, 2010

The Food and Drug Administration has approved a generic anxiety drug made by Actavis, the...