FDA Corrects Notice on Withdrawal of New Drug Applications and Abbreviated New Drug Applications

Summary

The US Food and Drug Administration (FDA) has corrected a notice that was published in the Federal Register on October 13, 2015, regarding the withdrawal of approval for 67 new drug applications and 128 abbreviated new drug applications. The FDA has reinstated the approval of two withdrawn applications, MINTEZOL (thiabendazole) Tablets and MINTEZOL (thiabendazole) Oral Suspension, after Merck Sharp & Dohme Corp. (Merck) requested that the FDA not withdraw approval.