Pharmaceutical Business review

FDA approves Talecris Biotherapeutics Gamunex-C

Through its FDA approval, Gamunex-C becomes the first and only immunoglobulin therapy approved in the US with both intravenous and subcutaneous routes of administration to treat PI, Talecris said.

The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP). The subcutaneous mode is approved to treat only PI.

Talecris Biotherapeutics discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology and hemostasis.