Content about Hypnotics

December 2, 2013

The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

NOIDA, India — The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

Jubilant announced the approval of quetiapine fumarate tablets in the 25-mg strength. The drug is a generic version of AstraZeneca's Seroquel.

Various versions of the drug have annual sales of about $59 million, according to IMS Health.

 

September 17, 2013

The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.

 

May 21, 2013

Drug maker Duchesnay USA has launched a new treatment for morning sickness, the company announced.

ROSEMONT, Pa. — Drug maker Duchesnay USA has launched a new treatment for morning sickness, the company said Tuesday.

April 9, 2013

The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

ROSEMONT, Pa. — The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

Drug maker Duchesnay USA said the FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets in the 10 mg/10 mg strength for NVP, more commonly known as morning sickness, in women who don't respond to conservative treatment. NVP is estimated to affect 70-85% of pregnant women, and symptoms range from nausea to severe vomiting and retching that can last throughout the day.

November 29, 2012

Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said.

Watson to change brand in 2013
PARSIPPANY, N.J. — Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said. Watson, whose $5.6 billion acquisition of Actavis received approval from the Federal Trade Commission in October, said it would adopt the new name starting in 2013, with plans to start a multi-year rebranding campaign and trade under a new symbol on the New York Stock Exchange.


October 29, 2012

Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

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.

March 26, 2012

A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

NEW YORK — A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

January 31, 2012

The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

The FDA approved Hi-Tech's lorazepam oral concentrate in the 2-mg-per-mL strength, a generic version of Roxanne Labs' Intensol.

Branded and generic versions of the drug had sales of $10 million in 2011, according to IMS Health.


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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 5, 2011

Zarbee's on Wednesday announced the launch of Zarbee's Nighttime Cough and Sleep Drink, an over-the-counter nighttime cough remedy.

SALT LAKE CITY — Zarbee's on Wednesday announced the launch of Zarbee's Nighttime Cough and Sleep Drink, an over-the-counter nighttime cough remedy.

Zarbee's Nighttime Cough and Sleep Drink is made from antioxidant-rich buckwheat honey, which recent clinical studies have shown is more effective at relieving coughs associated with colds and upper respiratory illnesses than dextromethorphan or diphenhydramine, the company claimed.

October 4, 2011

Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

SAN DIEGO — Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

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.

July 18, 2011

Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

June 7, 2011

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.

April 4, 2011

Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

TORONTO — Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

Intellipharmaceutics announced Monday that it had filed an application with the Food and Drug Administration for quetiapine fumarate extended-release tablets, a generic version of AstraZeneca’s Seroquel XR.

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.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

January 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

October 18, 2010

The Food and Drug Administration has approved a drug for treating insomnia made by Actavis,...

MORRISTOWN, N.J. The Food and Drug Administration has approved a drug for treating insomnia made by Actavis, the generic drug maker said Monday.

 

Actavis announced the approval of zolpidem tartrate extended-release tablets in the 6.25-mg strength. The company has begun shipping the drug.

 

 

The drug is a generic version of Sanofi-Aventis’ Ambien CR, which had sales of around $129 million during the 12-month period ended in June, according to IMS Health.

 

September 8, 2010

Residents in North Carolina prescribed controlled substances could receive some attention from more than their...

RALEIGH, N.C. Residents in North Carolina prescribed controlled substances could receive some attention from more than their physicians and pharmacists, according to published reports.

 

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....