ADMA Relaunches Bivigam After Three Year Interruption
ADMA Biologics relaunched its immunodeficiency drug Bivigam (immune globulin intravenous) after resolving production problems at its facility in Boca Raton, Florida that kept the product off the market for almost three years.
The FDA originally approved the firm’s biologics license application in 2012, but prevented a launch following production snags at a contract manufacturer acquired by ADMA. The agency granted approval for the “optimized” facility in May of this year.
The company said the relaunch will help alleviate shortages of immune globulin that have plagued U.S. hospitals since last year.