[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Page 31874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3208]


DHL Laboratories Inc.; Withdrawal of Approval of a New Drug 
Application for Dextrose 5% Injection in Plastic Container, 5 Grams/100 
Milliliters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of new drug application (NDA) 019971 for Dextrose 5% Injection in 
Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL 
Laboratories Inc., 155 Medical Science Dr., Union, SC 23979. The basis 
for the withdrawal is that the holder of the NDA has repeatedly failed 
to file required annual reports for the NDA.

DATES: Approval is withdrawn as of July 3, 2019.

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 holder of an approved application to 
market a new drug for human use is required to submit annual reports to 
FDA concerning its approved application in accordance with Sec.  314.81 
(21 CFR 314.81).
    In the Federal Register of August 29, 2018 (83 FR 44056), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of NDA 019971 because DHL Laboratories 
Inc. had failed to submit required annual reports for the NDA. DHL 
Laboratories Inc. did not respond to the NOOH. Failure to file a 
written notice of participation and request for hearing as required by 
Sec.  314.200 (21 CFR 314.200) constitutes an election by the holder of 
the NDA not to make use of the opportunity for a hearing concerning the 
proposal to withdraw approval of the NDA and a waiver of any 
contentions concerning the legal status of the drug product. FDA is 
withdrawing approval of NDA 019971 for Dextrose 5% Injection in Plastic 
Container, 5 g/100 mL.
    FDA finds that DHL Laboratories Inc. has repeatedly failed to 
submit reports required by Sec.  314.81. In addition, under Sec.  
314.200, FDA finds DHL Laboratories Inc. has waived any contentions 
concerning the legal status of the drug product. Therefore, under these 
findings, approval of NDA 019971, and all amendments and supplements 
thereto, is hereby withdrawn as of July 3, 2019.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14137 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P