Home » CHMP Recommends One Generic, Six Label Expansions at Latest Meeting
CHMP Recommends One Generic, Six Label Expansions at Latest Meeting
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.
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