FDA Sends Allergan Refuse-to-File Letter for Schizophrenia Drug sNDA

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.