Document ID: FDA-2016-N-1101-0001
Agency: fda
Document Type: Notice
Title: EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS
Posted Date: 2016-04-12T04:00Z

[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Page 21558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08336]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1101]

EMD Serono; Withdrawal of Approval of a New Drug Application for 
LUVERIS

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
withdrawing approval of a new drug application (NDA) for LUVERIS 
(lutropin alpha for injection) held by EMD Serono, One Technology 
Place, Rockland, MA 02370. EMD Serono has voluntarily requested that 
approval of this application be withdrawn, thereby waiving its 
opportunity for a hearing.

DATES: Effective April 12, 2016.

FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3381.

SUPPLEMENTARY INFORMATION: FDA approved LUVERIS (lutropin alpha for 
injection) on October 8, 2004, under the Agency's accelerated approval 
regulations, 21 CFR part 314, subpart H. LUVERIS is indicated for 
concomitant administration with GONAL-F (follitropin alfa for 
injection) for stimulation of follicular development in infertile 
hypogonadotropic hypogonadal women with profound luteinizing hormone 
deficiency. In a letter dated April 30, 2012, EMD Serono requested that 
FDA withdraw approval of NDA 021322 for LUVERIS under Sec.  314.150(c). 
In that letter, EMD Serono noted that, as had been previously discussed 
with the Agency, it was not feasible to complete a trial that the 
company had agreed to at the time of approval under subpart H. By 
letter dated December 8, 2014, FDA notified EMD Serono that, when 
studies that are required as a condition of approval under the Agency's 
accelerated approval regulations are not completed, the approval of an 
application is withdrawn according to the procedures set forth in 
Sec. Sec.  314.530 and 314.150(d) rather than under Sec.  314.150(c). 
FDA requested that EMD Serono submit a new withdrawal request under 
Sec.  314.150(d).
    Following additional correspondence, by letter dated July 23, 2015, 
EMD Serono requested that FDA withdraw approval of NDA 021322 for 
LUVERIS under Sec.  314.150(d) because a postmarketing study that was 
required as a condition of approval under subpart H was not completed. 
Because that study was required to verify and describe the clinical 
benefit of the drug product, the clinical benefit of LUVERIS has not 
been confirmed, and it has not been established to be safe and 
effective. In its July 23, 2015, letter, EMD Serono waived any 
opportunity for a hearing otherwise provided under Sec. Sec.  314.150 
and 314.530. FDA responded by letter dated September 2, 2015, 
acknowledging EMD Serono's request that FDA withdraw approval of 
LUVERIS under Sec.  314.150(d). FDA also acknowledged that EMD Serono 
waived its opportunity for a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and 
under authority delegated by the Commissioner to the Director, Center 
for Drug Evaluation and Research, approval of NDA 021322, and all 
amendments and supplements thereto, is withdrawn (see DATES). 
Distribution of this product in interstate commerce without an approved 
application is illegal and subject to regulatory action (see sections 
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08336 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P