© Reuters.
By 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.
A complete response letter notifies a company of the FDA’s completed review of data submitted in an application and any amendments. But according to the FDA, it usually delays a product’s entry into the market by an average of 14 months.
Teva and MedinCell, who it works with on the treatment, said they “remain committed to the development of risperidone and to providing patients with access to the product in the US, as quickly as possible.”
Teva added that it is reviewing the next steps based on the letter and will work closely with the FDA to address their recommendations.
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