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Teva Pharmaceuticals Slides After Receiving FDA Complete Response Letter -Breaking

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© Reuters.

Sam Boughedda

Investing.com — Teva Pharma Industries (NYSE:) stock has tumbled 4.7% Wednesday after the US Food and Drug Administration (FDA) issued a Complete Response Letter regarding the company’s New Drug Application (NDA) for its schizophrenia treatment, risperidone.

An FDA complete response letter informs a company that the FDA has completed its review of all data included in their application. It also includes any amendments. However, the FDA states that the FDA usually delays products’ entry to the market for an average of 14 month.

Teva and MedinCell are the partners in this treatment. They said that they remain committed to developing risperidone, and providing access for patients to it in the US as soon as possible.

Teva stated that they are currently reviewing next steps in light of the letter, and will be working closely with FDA to implement their suggestions.

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