FDA says Amgen's Vectibix promotional video is misleading, orders communications to cease
AMGN•The FDA found Amgen's Vectibix promotional video false or misleading because it omitted material risks, including dermatologic toxicity, infusion reactions and pulmonary fibrosis. It ordered Amgen to cease misleading promotional communications and said violations could lead to seizure and an injunction if not corrected.
1. FDA action
The FDA found Amgen's Vectibix promotional video false or misleading, citing omitted material risk information, including dermatologic toxicity, infusion reactions and pulmonary fibrosis. The agency ordered Amgen to cease misleading Vectibix promotional communications and said it could pursue seizure and an injunction if violations are not corrected.
