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.

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