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Imprese · 05/06/19981 min di lettura
KV Pharmaceutical Co.; Withdrawal of Approval of Two Abbreviated New Drug Applications and One Abbreviated Antibiotic Application
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Riepilogo
The Food and Drug Administration (FDA) is withdrawing approval of two abbreviated new drug applications (ANDA's) and one abbreviated antibiotic drug application (AADA) held by KV Pharmaceutical Co. (KV), 2503 South Hanley Rd., St. Louis, MO 63144. This action is being taken because the applications contain untrue statements of material fact, and the drugs covered by these applications lack substantial evidence of effectiveness.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →