Vanda Pharmaceuticals, Inc. v. FDA

Summary

The court held that the FDA and Teva improperly treated the different-manufacturer exception as permitting any safe, optional labeling variation. The exception permits only changes required by the change in manufacturers, so the FDA could not rely on it to approve removal of the braille dosage and associated pharmacy instructions. The court otherwise upheld the FDA's approval and arbitrary-and-capricious analysis, and remanded without vacatur for the agency to determine whether the generic label nonetheless satisfies the baseline requirement that it be the same as the brand label.