82 FR 18916 - Guerbet Group; Withdrawal of Approval of Two New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 77 (April 24, 2017)

Page Range		18916-18917
FR Document		2017-08179

The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Guerbet Group. Guerbet Group notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 82 Issue 77 (Monday, April 24, 2017)

[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18916-18917]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1748]


Guerbet Group; Withdrawal of Approval of Two New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new drug applications (NDAs) held by Guerbet Group. Guerbet 
Group notified the Agency in writing that the drug products were no 
longer marketed and requested that the approval of the applications be 
withdrawn.

DATES: Withdrawal of approval is effective May 24, 2017.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The applications listed in table 1 in this 
document are no longer marketed, and Guerbet Group has requested that 
FDA withdraw approval of the applications pursuant to the process in 
Sec.  314.150(c) (21 CFR 314.150(c)). The company has also, by its 
request, waived its opportunity for a hearing. Withdrawal of approval 
of an application or abbreviated application under Sec.  314.150(c) is 
without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
     Application No.                Drug                 Applicant
------------------------------------------------------------------------
NDA 018905..............  Hexabrix (ioxaglate      Guerbet Group, 821
                           meglumine and            Alexander Rd., Suite
                           ioxaglate sodium)        204, Princeton, NJ
                           Injection USP, 39.3%/    08540.
                           19.6%.

[[Page 18917]]

 
NDA 020316..............  Oxilan-300 and Oxilan-   Do.
                           350 (ioxilan)
                           Injection, 62% and 73%.
------------------------------------------------------------------------

    Therefore, under authority delegated to the Director, Center for 
Drug Evaluation and Research, by the Commissioner, approval of the 
applications listed in table 1 in this document, and all amendments and 
supplements thereto, is hereby withdrawn, effective May 24, 2017. 
Introduction or delivery for introduction into interstate commerce of 
products without approved new drug applications violates section 301(a) 
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) 
and (d)). Drug products that are listed in table 1 that are in 
inventory on the date that this notice becomes effective (see the DATES 
section) may continue to be dispensed until the inventories have been 
depleted or the drug products have reached their expiration dates or 
otherwise become violative, whichever occurs first.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08179 Filed 4-21-17; 8:45 am]
BILLING CODE 4164-01-P

18916 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices

animal origin from firms or processors information include U.S. producers of comment which was not PRA-related,
not on lists of eligible exporters for shell eggs, game meat and game meat and therefore is not addressed in this
these products are not eligible for export products, gelatin, and collagen. supporting statement.
certificates for these products, and these In the Federal Register of October 4,
FDA estimates the burden of this
products may be detained at EU ports of 2016 (81 FR 68424), FDA published a
60-day notice requesting public collection of information as follows:
entry.
Description of Respondents: The comment on the proposed collection of
respondents to this collection of information. FDA received one

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
Number of Total annual Average burden
Products responses per Total hours
respondents responses per response
respondent

Shell Eggs ..................................................... 10 1 10 .25 (15 minutes) ................... 3
Game Meat and Game Meat Products ........ 5 1 5 .25 (15 minutes) ................... 1
Gelatin ........................................................... 7 1 7 .25 (15 minutes) ................... 2
Collagen ........................................................ 18 1 18 .25 (15 minutes) ................... 5

Total ....................................................... ........................ ........................ ........................ ............................................... 11
1There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimates of the number for a total of seven annual responses. ACTION: Notice.
of respondents and total annual Each submission is estimated to take
responses on the submissions that we 0.25 hour per response for a total of 1.75 SUMMARY: The Food and Drug
have received in the past 3 years for hours, rounded to 2 hours. We estimate Administration (FDA) is withdrawing
each product type. To calculate the that we will receive 1 submission from approval of two new drug applications
estimate for the hours per response 18 collagen producers annually, for a (NDAs) held by Guerbet Group. Guerbet
values, we assumed that the information total of 18 annual responses. Each Group notified the Agency in writing
requested is readily available to the submission is estimated to take 0.25 that the drug products were no longer
submitter. We expect that the submitter hour per response for a total of 4.5 marketed and requested that the
will need to gather information from hours, rounded to 5 hours. The approval of the applications be
appropriate persons in the submitter’s estimated burden for collagen producers
company and to prepare this withdrawn.
includes animal casings, which have
information for submission. We believe been listed separately in previous DATES: Withdrawal of approval is
that this effort should take no longer notices. Therefore, the proposed annual effective May 24, 2017.
than 15 minutes (0.25 hour) per burden for this information collection is
response. We estimate that we will 11 hours. FOR FURTHER INFORMATION CONTACT:
receive 1 submission from 10 shell egg Florine P. Purdie, Center for Drug
Dated: April 17, 2017.
producers annually, for a total of 10 Evaluation and Research, Food and
Anna K. Abram,
annual responses. Each submission is Drug Administration, 10903 New
estimated to take 0.25 hour per response Deputy Commissioner for Policy, Planning, Hampshire Ave., Bldg. 51, Rm. 6248,
Legislation, and Analysis.
for a total of 2.5 hours, rounded to 3 Silver Spring, MD 20993–0002, 301–
hours. This collection has previously [FR Doc. 2017–08181 Filed 4–21–17; 8:45 am]
796–3601.
covered information collected to BILLING CODE 4164–01–P
maintain lists of eligible exporters of SUPPLEMENTARY INFORMATION: The
dairy products; dairy products will be applications listed in table 1 in this
covered under OMB control number DEPARTMENT OF HEALTH AND document are no longer marketed, and
0910–0509, so the estimated burden has HUMAN SERVICES Guerbet Group has requested that FDA
been removed from this collection. We withdraw approval of the applications
Food and Drug Administration
estimate that we will receive one pursuant to the process in § 314.150(c)
submission from five game meat and (21 CFR 314.150(c)). The company has
[Docket No. FDA–2017–N–1748]
game meat product producers annually, also, by its request, waived its
for a total of five annual responses. Each Guerbet Group; Withdrawal of opportunity for a hearing. Withdrawal
submission is estimated to take 0.25 Approval of Two New Drug of approval of an application or
hour per response for a total of 1.25 Applications abbreviated application under
hours, rounded to 1 hour. We estimate § 314.150(c) is without prejudice to
that we will receive one submission AGENCY: Food and Drug Administration, refiling.
from seven gelatin producers annually, HHS.

TABLE 1
jstallworth on DSK7TPTVN1PROD with NOTICES

Application No. Drug Applicant

NDA 018905 .......... Hexabrix (ioxaglate meglumine and ioxaglate sodium) Injection Guerbet Group, 821 Alexander Rd., Suite 204, Princeton,
USP, 39.3%/19.6%. NJ 08540.

VerDate Sep<11>2014 17:25 Apr 21, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1

Document Created: 2017-04-22 00:11:09
Document Modified: 2017-04-22 00:11:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Withdrawal of approval is effective May 24, 2017.
Contact		Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601.
FR Citation		82 FR 18916

82 FR 18916 - Guerbet Group; Withdrawal of Approval of Two New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 77 (April 24, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration