DHL Laboratories Inc.; Withdrawal of Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container, 5 Grams/100 Milliliters, 31874 [2019-14137]
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31874
Federal Register / Vol. 84, No. 128 / Wednesday, July 3, 2019 / Notices
Cardinal Health Regulatory Sciences
submitted a citizen petition dated
January 31, 2019 (Docket No. FDA–
2019–P–1366), under 21 CFR 10.30,
requesting that the Agency determine
whether CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
CLAFORAN (cefotaxime sodium) for
injection, 500 mg/vial, 1 g/vial, 2 g/vial
and 10 g/vial from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14172 Filed 7–2–19; 8:45 am]
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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,
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
HHS.
ACTION:
Notice.
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 § 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
§ 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 § 314.81. In addition, under
§ 314.200, FDA finds DHL Laboratories
Inc. has waived any contentions
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1114]
Pharmaceutical Distribution Supply
Chain Pilot Projects; Reopening of
Comment Period; Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of comment
period; request for information.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notices (requests for information) that
published in the Federal Register of
April 15, 2016, and April 28, 2017. FDA
is requesting comments regarding issues
related to utilizing the product identifier
for product tracing, improving the
technical capabilities of the supply
chain, and identifying system attributes
that are necessary to implement the
requirements established under the
Drug Supply Chain Security Act
(DSCSA). The information gathered
from reopening of the comment period
will allow supply chain stakeholders to
share information about relevant
piloting activities that are conducted
outside of FDA’s DSCSA Pilot Project
Program to inform DSCSA
implementation by FDA and supply
chain stakeholders.
DATES: FDA is reopening the comment
period on the notices (requests for
information) published April 15, 2016
(81 FR 22279), and April 28, 2017 (82
FR 19737). Submit either electronic or
written comments by June 28, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 28, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 28, 2022. Comments
received by mail/hand delivery/courier
SUMMARY:
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
