81_FR_21628 81 FR 21558 - EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS

81 FR 21558 - EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 70 (April 12, 2016)

Page Range21558-21558
FR Document2016-08336

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 EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

Federal Register, Volume 81 Issue 70 (Tuesday, April 12, 2016) 
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Page 21558]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08336]


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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.

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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approval of this application be withdrawn, thereby waiving its 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

21558 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices Research Center. February 11, 2008. (http:// infertile hypogonadotropic hypogonadal DEPARTMENT OF HEALTH AND pewhispanic.org/files/reports/85.pdf). women with profound luteinizing HUMAN SERVICES 3. Quinlan, J.J. ‘‘Foodborne Illness hormone deficiency. In a letter dated Incidence Rates and Food Safety Risks for Food and Drug Administration Populations of Low Socioeconomic Status April 30, 2012, EMD Serono requested and Minority Race/Ethnicity: A Review of the that FDA withdraw approval of NDA [Docket No. FDA–2012–N–0560] Literature.’’ International Journal of 021322 for LUVERIS under § 314.150(c). Environmental Research and Public Health In that letter, EMD Serono noted that, as Agency Information Collection 10(8): 3634–3652, 2013. had been previously discussed with the Activities; Submission for Office of 4. Taylor, P., M.H. Lopez, J. Martı́nez and Agency, it was not feasible to complete Management and Budget Review; G.Velasco. ‘‘Language Use Among Latinos.’’ a trial that the company had agreed to Comment Request; Guidance on Pew Research Center. April 4, 2012. (http:// Informed Consent for In Vitro at the time of approval under subpart H. www.pewhispanic.org/2012/04/04/iv- language-use-among-latinos/). By letter dated December 8, 2014, FDA Diagnostic Device Studies Using 5. Henley, S.C., S.E. Stein and J.J. Quinlan. notified EMD Serono that, when studies Leftover Human Specimens ‘‘Identification of Unique Food Handling that are required as a condition of AGENCY: Food and Drug Administration, Practices That Could Represent Food Safety approval under the Agency’s accelerated HHS. Risks for Minority Consumers.’’ Journal of approval regulations are not completed, Food Protection 75: 2050–2054, 2012. ACTION: Notice. the approval of an application is 6. Marin, G., F. Sabogal, B.V. Marin, et al. withdrawn according to the procedures SUMMARY: The Food and Drug ‘‘Development of a Short Acculturation Scale set forth in §§ 314.530 and 314.150(d) Administration (FDA) is announcing for Hispanics.’’ Hispanic Journal of Behavioral Sciences 9(2): 183–205, 1987. rather than under § 314.150(c). FDA that a proposed collection of requested that EMD Serono submit a information has been submitted to the Dated: April 6, 2016. new withdrawal request under Office of Management and Budget Leslie Kux, § 314.150(d). (OMB) for review and clearance under Associate Commissioner for Policy. Following additional correspondence, the Paperwork Reduction Act of 1995. [FR Doc. 2016–08332 Filed 4–11–16; 8:45 am] by letter dated July 23, 2015, EMD DATES: Fax written comments on the BILLING CODE 4164–01–P Serono requested that FDA withdraw collection of information by May 12, approval of NDA 021322 for LUVERIS 2016. under § 314.150(d) because a ADDRESSES: To ensure that comments on DEPARTMENT OF HEALTH AND postmarketing study that was required the information collection are received, HUMAN SERVICES as a condition of approval under subpart OMB recommends that written H was not completed. Because that comments be faxed to the Office of Food and Drug Administration study was required to verify and Information and Regulatory Affairs, [Docket No. FDA–2016–N–1101] describe the clinical benefit of the drug OMB, Attn: FDA Desk Officer, FAX: product, the clinical benefit of LUVERIS 202–395–7285, or emailed to oira_ EMD Serono; Withdrawal of Approval has not been confirmed, and it has not submission@omb.eop.gov. All of a New Drug Application for LUVERIS been established to be safe and effective. comments should be identified with the AGENCY: Food and Drug Administration, In its July 23, 2015, letter, EMD Serono OMB control number 0910–0582. Also HHS. waived any opportunity for a hearing include the FDA docket number found otherwise provided under §§ 314.150 in brackets in the heading of this ACTION: Notice. and 314.530. FDA responded by letter document. SUMMARY: The Food and Drug dated September 2, 2015, FOR FURTHER INFORMATION CONTACT: FDA Administration (FDA or the Agency) is acknowledging EMD Serono’s request PRA Staff, Office of Operations, Food withdrawing approval of a new drug that FDA withdraw approval of and Drug Administration, 8455 application (NDA) for LUVERIS LUVERIS under § 314.150(d). FDA also Colesville Rd., COLE–14526, Silver (lutropin alpha for injection) held by acknowledged that EMD Serono waived Spring, MD 20993–0002, PRAStaff@ EMD Serono, One Technology Place, its opportunity for a hearing. fda.hhs.gov. Rockland, MA 02370. EMD Serono has Therefore, under section 505(e) of the SUPPLEMENTARY INFORMATION: In voluntarily requested that approval of Federal Food, Drug, and Cosmetic Act this application be withdrawn, thereby compliance with 44 U.S.C. 3507, FDA (FD&C Act) (21 U.S.C. 355(e)) and has submitted the following proposed waiving its opportunity for a hearing. § 314.150(d), and under authority collection of information to OMB for DATES: Effective April 12, 2016. delegated by the Commissioner to the review and clearance. FOR FURTHER INFORMATION CONTACT: Director, Center for Drug Evaluation and Emily Helms Williams, Center for Drug Research, approval of NDA 021322, and Guidance on Informed Consent for In Evaluation and Research, Food and all amendments and supplements Vitro Diagnostic Device Studies Using Drug Administration, 10903 New thereto, is withdrawn (see DATES). Leftover Human Specimens That Are Hampshire Ave., Bldg. 51, Rm. 6280, Distribution of this product in interstate Not Individually Identifiable—OMB Silver Spring, MD 20993–0002, 301– commerce without an approved Control Number 0910–0582—Extension 796–3381. application is illegal and subject to FDA’s investigational device SUPPLEMENTARY INFORMATION: FDA regulatory action (see sections 505(a) regulations are intended to encourage asabaliauskas on DSK3SPTVN1PROD with NOTICES approved LUVERIS (lutropin alpha for and 301(d) of the FD&C Act (21 U.S.C. the development of new, useful devices injection) on October 8, 2004, under the 355(a) and 331(d)). in a manner that is consistent with Agency’s accelerated approval Dated: April 6, 2016. public health, safety, and compliant regulations, 21 CFR part 314, subpart H. with ethical standards. Investigators Leslie Kux, LUVERIS is indicated for concomitant should have freedom to pursue the least administration with GONAL–F Associate Commissioner for Policy. burdensome means of accomplishing (follitropin alfa for injection) for [FR Doc. 2016–08336 Filed 4–11–16; 8:45 am] this goal. However, to ensure that the stimulation of follicular development in BILLING CODE 4164–01–P balance is maintained between product VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1


Document Created: 2016-04-12 00:46:37
Document Modified: 2016-04-12 00:46:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesEffective April 12, 2016.
ContactEmily 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.
FR Citation81 FR 21558 
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