Content about Atypical antipsychotics

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.

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.

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.

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.

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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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.

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.

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.

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.

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.

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.