www.fdanews.com/articles/183718-fda-sends-allergan-refuse-to-file-letter-for-schizophrenia-drug-snda
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FDA Sends Allergan Refuse-to-File Letter for Schizophrenia Drug sNDA
September 28, 2017
Allergan received a refusal-to-file letter from the FDA regarding its sNDA for Vraylar (cariprazine), a treatment for schizophrenia symptoms.
The agency conducted a preliminary review and concluded that the sNDA was insufficiently complete for a more substantive review, according to the company.
In the company’s announcement, Allergan Chief Research and Development Officer David Nicholson said the company will seek a meeting with the agency to discuss next steps and clarify what further information it needs. Cariprazine is currently approved in Europe for treatment of schizophrenia.