Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-Release Tablets, 400 Milligrams

الملخص

The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612 (Allergan). Pursuant to FDA's request, Allergan agreed to withdrawal of this application and has waived its opportunity for a hearing.