No one can sell a new drug without prior approval from the FDA. That rule is codified in the federal Food, Drug, and Cosmetic Act and is not controversial (or at least should not be controversial). Less clear is whether a seller of an FDA-approved drug can sue a competitor under state unfair competition laws
Earlier this week a district court dismissed claims brought against the manufacturer and the distributor of a generic drug, holding that all of the claims were preempted by federal law and the several also failed under Florida law. The decision, Hernandez v. Aurobindo Pharma USA, Inc., 2022 WL 204401 (M.D. Fla. 2022), is long