FDA Declined Approval of New Antipsychotic Drug

U.S. health regulators have declined to approve a new antipsychotic drug, cariprazine (for schizophrenia and bipolar disorder), from Forest Laboratories and Richter. They cited the need for more information, including likely additional clinical trial data.

….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.

“This is likely to cause a delay … (but) we cannot tell how much; we will be able to tell after consultations with the FDA,” said Richter spokeswoman Zsuzsa Beke.


Full Article

Speak Your Mind