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

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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.