Organon USA et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications; Correction

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The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 13, 2015 (80 FR 61426). The document announced the withdrawal of approval of 67 new drug applications (NDAs) and 128 abbreviated new drug applications from multiple applicants, effective November 12, 2015. The document indicated that FDA was withdrawing approval of the following two NDAs after receiving a request from the NDA holder, Merck Sharp & Dohme Corp. (Merck), 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889: NDA 016096, MINTEZOL (thiabendazole) Tablets, and NDA 016097, MINTEZOL (thiabendazole) Oral Suspension. Before withdrawal of these NDAs became effective, Merck informed FDA that it did not want approval of the NDAs withdrawn. Because Merck timely requested that approval of these NDAs not be withdrawn, the approval of NDAs 016096 and 016097 is still in effect.