Content about Atypical antipsychotics

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.

 

July 1, 2013

The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said.

MARLBOROUGH, Mass. — The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said Monday.

The FDA has approved Latuda (lurasidone hydrochloride) for use either alone or combined with lithium or valproate in patients with bipolar depression. The drug was already approved for treating schizophrenia.

March 1, 2013

The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

January 15, 2013

Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.

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.

August 23, 2012

Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.

April 25, 2012

Sun Pharmaceutical Industries has launched a generic version of a drug used to treat psychiatric disorders, the company said.

MUMBAI, India — Sun Pharmaceutical Industries has launched a generic version of a drug used to treat psychiatric disorders, the company said.

Sun announced the launch of olanzapine tablets in the 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths.

The drug is a generic version of Eli Lilly's Zyprexa, used to treat schizophrenia and bipolar disorder. The branded drug and generic versions had sales of $3.28 billion during the 12-month period ended in January, according to IMS Health.

 

April 24, 2012

Dr. Reddy's Labs has launched a generic version of an Eli Lilly drug used to treat psychiatric disorders, the company said Tuesday.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic version of an Eli Lilly drug used to treat psychiatric disorders, the company said Tuesday.

Dr. Reddy's announced the launch of olanzapine tablets in the 2.5-mg, 5-mg, 7.5-mg, 10-mg and 15-mg strengths.

The drug is a generic version of Zyprexa, used to treat schizophrenia and bipolar disorder. Generic and branded versions of the drug had sales of about $3.28 billion during the 12-month period ended in January, according to IMS Health.

April 24, 2012

Mylan has launched a generic drug for treating psychiatric disorders, the company said Tuesday.

PITTSBURGH — Mylan has launched a generic drug for treating psychiatric disorders, the company said Tuesday.

Mylan announced the launch of olanzapine tablets in the 2.5-mg, 5-mg, 7.5-mg, 10-mg, 15-mg and 20-mg strengths.

The drug, a generic version of Eli Lilly's Zyprexa, is used to treat schizophrenia and bipolar disorder. Various versions of the drug had sales of about $3.3 billion in 2011, according to IMS Health.

March 28, 2012

Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

NEW YORK — Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

Dr. Reddy's Labs, Teva and Mylan announced Wednesday the launch of their respective versions of quetiapine fumarate tablets, generic formulations of AstraZeneca's Seroquel, in strengths ranging from 25 mg to 400 mg.

March 5, 2012

Indian drug maker Dr. Reddy's has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.

The company announced the launch of ziprasidone hydrochloride capsules in the 20-mg, 40-mg, 60-mg and 80-mg strengths.

The drug is a generic version of Pfizer's Geodon, which had sales of $1.34 billion in 2011, according to IMS Health.

February 3, 2012

Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

NORTH WALES, Pa. — Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

Teva announced the launch of olanzapine orally disintegrating tablets in the 5-mg, 10-mg, 15-mg and 20-mg strengths in blister packs of 30.

The drug is a generic version of Eli Lilly's Zyprexa Zydis, used to treat schizophrenia and bipolar disorder.


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December 14, 2011

A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

MOUNTAIN VIEW, Calif. — A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

October 27, 2011

A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

PISCATAWAY, N.J. — A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

Innopharma said its abbreviated new drug application for olanzapine injection, a generic equivalent of Zyprexa injection. With this approval, Innopharma announced that it has entered an agreement with Sandoz, who will sell, market and distribute Innopharma's generic in the United States.

October 25, 2011

Dr. Reddy's Labs reported sales of $462 million for second quarter 2012 and $866 million for the first half of the fiscal year, according to an earnings statement released Tuesday.

HYDERABAD, India — Dr. Reddy's Labs reported sales of $462 million for second quarter 2012 and $866 million for the first half of the fiscal year, according to an earnings statement released Tuesday.

The Indian generic drug maker said the second-quarter sales represented a 21% increase over second quarter 2011. Sales from global generics were $329 million for the quarter, an 18% increase over second quarter 2011, driven mostly by growth in North America and Russia.

Profits for the quarter were $63 million, a 7% increase over second quarter 2011.

October 24, 2011

The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly's Zyprexa and Zyprexa Zydus. Dr. Reddy's Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy's, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.

October 7, 2011

Anglo-Swedish drug maker AstraZeneca has settled patent infringement lawsuits that it filed against two companies that had sought to market generic versions of one of its drugs.

NEW YORK — Anglo-Swedish drug maker AstraZeneca has settled patent infringement lawsuits that it filed against two companies that had sought to market generic versions of one of its drugs.

The company settled with Handa Pharmaceuticals and also with Accord Healthcare and Intas Pharmaceuticals over two generic versions of the bipolar disorder and schizophrenia treatment Seroquel XR (quetiapine fumarate) extended-release tablets.

September 28, 2011

A new report from the Department of Health and Human Services' Agency for Healthcare Research and Quality found little evidence to support the use of atypical antipsychotic drugs for uses other than those for which they have official approval.

ROCKVILLE, Md. — A new report from the Department of Health and Human Services' Agency for Healthcare Research and Quality found little evidence to support the use of atypical antipsychotic drugs for uses other than those for which they have official approval.

July 11, 2011

Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.

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 17, 2011

The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.

PRINCETON, N.J. — The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.

The FDA approved Abilify (aripiprazole), made by Bristol-Myers Squibb and Otsuka Pharmaceutical, as an adjunct to lithium or valproate for maintenance treatment of bipolar I disorder.

October 28, 2010

The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency...

SILVER SPRING, Md. The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency said Thursday.

The FDA announced the approval of Latuda (lurasidone hydrochloride), made by Fort Lee, N.J.-based Sunovion Pharmaceuticals. The drug is approved to treat adults with the disease, a mental illness that causes hallucinations, delusions, paranoia and disordered thinking and behavior.

September 8, 2010

Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug...

WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

August 10, 2010

The drug market for unipolar depression will get smaller over the next decade due to...