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FDA Watch: Approval for Grifols; designation for Novartis

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 11.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Approvals

* Grifols SA's Erytra Eflexis, to analyze the compatibility of blood between transfusion recipients and donors.

Breakthrough therapy

* Novartis AG's crizanlizumab, to prevent vaso-occlusive crises in patients with sickle cell disease. Novartis said it plans to file for FDA approval of the drug, also known as SEG101, in the first half of 2019.