KV Pharmaceutical Co.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications and One Abbreviated Antibiotic Drug Application; Opportunity for a Hearing

概要

The Food and Drug Administration (FDA) is proposing to withdraw approval of two abbreviated new drug applications (ANDA's) and one abbreviated antibiotic application (AADA) held by KV Pharmaceutical Co., 2503 South Hanley Rd., St. Louis, MO 63144 (KV). The grounds for the proposed withdrawals are (1) that the applications contain untrue statements of material fact; and (2) that based upon new information evaluated together with the evidence available when the applications were approved, there is a lack of substantial evidence that the drugs will have the effect they purport or are represented to have under the conditions of use prescribed, recommended, or suggested in their labeling.