FDA Declines to Approve New Antipsychotic Drug

November 22, 2013

(Reuters) - U.S. health regulators have declined to approve a new antipsychotic drug from Forest Laboratories and Richter, citing the need for more information, including additional clinical trial data.

The Food and Drug Administration (FDA) delivered its verdict on cariprazine for schizophrenia and bipolar disorder in a so-called "complete response letter," the type of letter issued by the agency to convey that it cannot approve a drug application in its current form.

In its letter, the FDA acknowledged that cariprazine demonstrated effectiveness but the two companies said on Thursday it appeared regulators wanted more tests on the optimal dose of the treatment to avoid potential side effects.

Cariprazine was discovered by Hungarian drugmaker Richter and licensed to Forest in the United States and Canada.

Industry analysts have forecast North American sales of the drug of $250 million in 2017, according to consensus forecasts compiled by Thomson Reuters Pharma.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.