December 19, 2018 / 11:14 PM / a month ago

FDA declines to approve re-launch of ADMA Biologics' Bivigam

Dec 19 (Reuters) - The U.S. Food and Drug Administration on Wednesday declined to approve ADMA Biologics Inc's application to re-launch its immune deficiency treatment Bivigam, the company said.

The FDA decision comes more than two years after the drug's previous owner suspended its production.

Bivigam is a treatment given through the veins for patients with primary humoral immunodeficiency, a condition that compromises the body's ability to fight infections. (Reporting by Manogna Maddipatla and Aakash Jagadeesh Babu in Bengaluru; Editing by James Emmanuel)

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