D.C. Circuit Upholds Approval Of Drug; Not ‘Same’ Under Orphan Drug Act

( July 2, 2025, 10:54 AM EDT) -- WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals found that the U.S. Food and Drug Administration’s approval of a drug to treat narcolepsy during Jazz Pharmaceuticals Inc.’s seven-year exclusivity period for a drug containing the same active ingredient approved for the same disease or condition did not violate the Administrative Procedure Act (APA)....