www.fdanews.com/articles/184065-chmp-recommends-one-generic-six-label-expansions-at-latest-meeting
CHMP Recommends One Generic, Six Label Expansions at Latest Meeting
October 20, 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use had a light meeting load this month, recommending approval for a single generic medicine and expansions of indications for six other drugs.
The CHMP recommended that Tacforius (tacrolimus) — a Teva-developed generic of the immunosuppressive drug first made by Astellas Pharma — be approved for the prophylaxis and treatment of transplant rejections, marking the 75th drug to receive a positive opinion so far this year.
The committee recommended expanding indications for Alecensa, Bydureon, Cubicin, Faslodex, Pegasys and Zytiga.