PDA

View Full Version : CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets


News
06-25-2010, 05:15 AM
Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

More... (http://www.news-medical.net/news/20100625/CHMP-adopts-positive-opinion-on-pending-MAA-for-SYCREST-sublingual-tablets.aspx)