Hance Brothers and White Co., et al.; Proposal to Withdraw Approval of 17 Abbreviated Applications; Opportunity for a Hearing

摘要

The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 3 abbreviated antibiotic applications (AADA's) and 14 abbreviated new drug applications (ANDA's). The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.