Business · 14/01/19971 min read

FDA Proposes Withdrawal of Terfenadine Drug Approvals Amid Safety Concerns

The Food and Drug Administration (FDA) is proposing to withdraw approval of two new drug applications (NDAs) and one abbreviated new drug application (ANDA) for terfenadine-containing drug products, citing concerns over the risk of serious side effects, following the approval of a safer alternative, fexofenadine hydrochloride (Allegra).