FDA WARNING_LETTER - Octapharma USA, Inc.

The FDA issued a Warning Letter to Octapharma USA, Inc. regarding promotional materials for Octagam (Immune Globulin Intravenous (Human) 5%). The Advertising and Promotional Labeling Branch (APLB) reviewed journal advertisements from December 2011 in the BDI Pharma Product Catalog and BioSupply Trends Quarterly.

The FDA found the promotional material to be false and misleading due to the omission of risk information, specifically the boxed warning for potential acute renal dysfunction and renal failure, as well as other important safety information like contraindications, warnings, precautions, and adverse reactions. This misbrands Octagam under Sections 502(n) and 201(n) of the Federal Food, Drug, and Cosmetic Act and 21 CFR §202.1(e). Additionally, Octapharma failed to submit these promotional materials to CBER at the time of initial dissemination, violating 21 CFR §601.12(f)(4).

The FDA noted a history of similar violations, including a Warning Letter on August 31, 2005, and a teleconference reminder on October 13, 2009, regarding submission requirements. The letter emphasizes that reminder advertising is not permitted for Octagam due to its boxed warning.

Octapharma is required to immediately cease disseminating the violative materials and submit a written response within ten business days. This response must confirm compliance, list all