KV Pharmaceutical Co.; Withdrawal of Approval of Two Abbreviated New Drug Applications and One Abbreviated Antibiotic Application

Streszczenie

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.