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April 29, 2015

FDA grants approval for generic version of antipsychotic drug Abilify

The US Food and Drug Administration (FDA) has granted approval for the first generic versions of Abilify (aripiprazole), which is an atypical antipsychotic drug to treat schizophrenia and bipolar disorder.

Teva

The US Food and Drug Administration (FDA) has granted approval for the first generic versions of Abilify (aripiprazole), which is an atypical antipsychotic drug to treat schizophrenia and bipolar disorder.

The approval has been granted to Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals to sell generic aripiprazole in multiple strengths and dosage forms.

Schizophrenia is a chronic, severe and disabling brain disorder, while bipolar disorder or manic-depressive illness is an another brain disorder that will cause unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.

FDA Center for Drug Evaluation and Research office of generic drugs acting director Dr John Peters said: "Having access to treatments is important for patients with long-term health conditions.

"We are pleased to launch generic Aripiprazole tablets and offer a generic treatment for patients suffering from schizophrenia and bipolar I disorder."

"Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug."

Following the approval, Teva announced the launch of the generic equivalent to Abilify tablets in the US.

The company has launched the tablets in different dosage forms, including 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg.

Marketed by Otsuka Pharmaceutical, Abilify reported annual sales of around $7.8bn in the US, according to IMS data as of December 2014.

Teva global generic medicines president and CEO Siggi Olafsson: "We are pleased to launch generic Aripiprazole tablets and offer a generic treatment for patients suffering from schizophrenia and bipolar I disorder."


Image: Image showing brain areas more active in controls than in schizophrenia patients during a working memory task during a fMRI study. Photo: Kim J, Matthews NL, Park S.

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