Eisai, Inc.; Withdrawal of Approval of Two New Drug Application for BELVIQ (lorcaserin hydrochloride) and BELVIQ XR (lorcaserin hydrocholoride)

摘要

The Food and Drug Administration (FDA) is withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended- release tablets held by Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ 07677 (Eisai). Eisai requested withdrawal of these applications and has waived its opportunity for a hearing.