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# FDA Withdraws Luveris NDA
- URL: https://www.fdaweb.com/fda-withdraws-luveris-nda/
- Published: 2016-04-12T12:00:00.000Z
- Updated: 2026-09-14T20:54:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135344

*Federal Register* Notice: FDA is withdrawing approval of an EMD Serono NDA for Luveris (lutropin alpha for injection). The company has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08336.pdf?ref=fdaweb.com)