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Teva's prophylaxis generic gets sole EMA recommendation in October

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of one generic medicine in October: Teva Pharmaceutical Industries Ltd.'s Tacforius, intended for prophylaxis and treatment of transplant rejection.

Separately, the EU panel recommended Roche Holding AG's Alecensa as a first-line treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. The drug was previously recommended as monotherapy for patients that had already been treated with Pfizer Inc.'s Xalkori, or crizotinib.

Santhera Pharmaceuticals Holding AG requested a reexamination of the CHMP's negative opinion for Raxone, or idebenone, intended to treat Duchenne muscular dystrophy, a rare genetic condition characterized by progressive muscle weakness and degeneration. The EMA panel will re-examine the opinion and issue a final recommendation.

The CHMP did not adopt a negative opinion in its October meeting. Also, no company withdrew its application during the month.