Breckenridge Pharmaceutical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 Milligrams and 10 Milligrams

摘要

The Food and Drug Administration (FDA) is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Berlin, CT 06037 (Breckenridge). Breckenridge requested withdrawal of this application and has waived its opportunity for a hearing.