EMEA didn’t approve treatment of fibromyalgia as a new indication for pregabalin (Lyrica).The CHMP was concerned that the benefits of Lyrica in fibromyalgia had not been shown in either the short or the long term.
Efalizumab (Raptiva) for plaque psoriasis. EMEA recommends withdrawal of its marketing authorization, FDA issues public health advisory
Raptiva and progressive multifocal leukoencephalopathy : EMEA recommends withdrawal of marketing authorization and FDA recommends monitoring patients.
Excerpts from the EMEA press release (dated 17th February) on the withdrawal of the marketing application for Vorinostat MSD: The European Medicines Agency (EMEA) has been formally notified by Merck Sharp & Dohme Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Vorinostat MSD (vorinostat), 100 mg hard […]