FDA Federal Register (withdrawal of approval)·2026-10-09 00:00· 2026-10-09AI 评分45

FDA 认定 LASIX（呋塞米）口服溶液（10 mg/mL）并非因安全或有效性原因停售

Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AI 导读

FDA 发布通告认定，LASIX（呋塞米，furosemide）10 mg/mL 口服溶液并非因安全或有效性原因停止销售。据此，FDA 不会启动撤回涉及该产品的简略新药申请（ANDA）批准的程序，并可在满足相关法律和监管要求的前提下继续批准此类申请。