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)

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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, 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withdrawn.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
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     Application No.                Drug                 Applicant
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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%.
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    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