Pharmaceutical Company Says FDA’s Approval Of Generic Drug Violated FDCA

(April 25, 2024, 2:20 PM EDT) -- WASHINGTON, D.C. — A pharmaceutical company moved for summary judgment in its suit against the U.S. Food and Drug Administration, asking a federal judge in the District of Columbia to order that the FDA vacate its approval of the abbreviated new drug application (ANDA) for generic tasimelteon and recall the drug....