Octapharma Warned on Journal Advertising for Immune System Drug

The FDA has warned Octapharma over journal ads for its Octagam injection for immune system disorders, as the ads lack risk information and misbrand the product. The April 10 letter sharply criticizes the company for its “continued violative promotion” of products and cites a 2005 warning letter for similar violations on Octagam (immune globulin IV). Further, in a 2009 teleconference, the agency reminded Octapharma that promotional materials must be submitted for review at the time of use. The recently posted warning notes the Swiss-based company failed to submit these ads to CBER at the time of dissemination.
Drug Industry Daily