BioCentury
ARTICLE | Company News

Roche sales and marketing update

February 6, 2012 8:00 AM UTC

Roche stopped releasing Mircera methoxy polyethylene glycol-epoetin beta and Xenical orlistat after finding GMP deficiencies at its Florence, S.C., manufacturing facility. Roche said it agreed with U.S. and European health authorities to continue releasing other products manufactured at the site including: intermediates and API used in influenza drug Tamiflu oseltamivir, cancer drug Xeloda capecitabine and cytomegalovirus (CMV) drug Valcyte valganciclovir. The pharma said it was working with health agencies, including FDA and EMA, but refrained from giving a timeline to start releasing the drugs again. ...