Forest’s Antipsychotic Cariprazine Clears Last Clinical Hurdle To Double NDA Filing In 2012
This article was originally published in The Pink Sheet Daily
Executive Summary
Specialty pharma has data in hand to support a double filing of novel antipsychotic cariprazine this year for acute exacerbation of schizophrenia and bipolar mania, with studies ongoing to support two additional indications in MDD.
You may also be interested in...
Additional Cariprazine Trial Could Put Forest In A Better Competitive Position
FDA “complete response” letter seeks another trial to better define the most tolerable dose, which could get the atypical antipsychotic to market in a better position than the original dataset.
Additional Cariprazine Trial Could Put Forest In A Better Competitive Position
FDA “complete response” letter seeks another trial to better define the most tolerable dose, which could get the atypical antipsychotic to market in a better position than the original dataset.
Teva’s U.S. Generic Sales Rebound With Late-Year Launches, Ranbaxy Lipitor Deal
The Israel-based manufacturer saw its full-year U.S. generic revenues drop 32% due to expired marketing exclusivities and manufacturing problems at two plants. However, the fourth quarter brought a rebound, thanks to launches of generic Zyprexa and Combivir and a profit-sharing agreement on atorvastatin.