Generic Labels Must Reflect Current FDA Labeling Rules, D.C. Circuit Court Says

WASHINGTON, D.C. - A generic drug's label must reflect the Food and Drug Administration's current labeling requirements and not those found on the label of the "listed" drug on which it is based, a federal appeals panel said March 12 in affirming summary judgment against a drug maker that challenged the agency's approval of a generic drug (Hill Dermaceuticals, Inc. v. Food & Drug Administration, et al., No. 12-5182, D.C. Cir.)....(read more)