Clay-Park Labs, Inc.; Withdrawal of Approval of Three Abbreviated Applications

الملخص

The Food and Drug Administration (FDA) is withdrawing approval of one abbreviated antibiotic drug application (AADA) and two abbreviated new drug applications (ANDA's) held by Clay-Park Labs, Inc., 1700 Bathgate Ave., Bathgate Industrial Park, Bronx, NY 10457 (Clay-Park). FDA is withdrawing approval of these applications because of questions raised about the reliability of the data and information submitted to FDA in support of the applications. Clay-Park requested this withdrawal and in so doing has waived its opportunity for a hearing.