December 19, 2018 / 11:13 PM / a year 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)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below