HOBOKEN, N.J. — A drug for treating immune system disorders is available again following a voluntary market withdrawal last summer.
Octapharma USA said Wednesday that Octagam (immune globulin intravenous [human] 5% liquid preparation) again was available for purchase. The Food and Drug Administration approved its reintroduction on Nov. 3.
The company started a voluntary market withdrawal of the 5% strength of the drug in August 2010 after patients reported internal blood clots known as thromboembolic events, in which a clot or thrombus forms locally in a blood vessel or breaks loose and blocks another vessel.
"It is a very exciting time for patients throughout the United States as they again have access to Octagam 5%, a therapy that has long been valued by the medical community for patient tolerability," Octapharma USA president Flemming Nielsen said. "We have seen over the last year that there are industry-wide concerns over [thromboembolic events] connected with multiple immune globulin products that remained on the market while we have implemented enhanced safety measures for Octagam 5%."