Nov 21 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.
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.
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.