Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE 148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 42899-42900 [2018-18311]
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Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
25. Osmanov, A. and D.W. Denning, ‘‘Burden
of Serious Fungal Infections in Ukraine,’’
Mycoses, 58(Suppl 5): 94–100, October
2015.
26. Morrow, B.M., N.Y. Hsaio, M. Zampoli,
et al., ‘‘Pneumocystis Pneumonia in
South African Children with and
Without Human Immunodeficiency
Virus Infection in the Era of Highly
Active Antiretroviral Therapy,’’ The
Pediatric Infectious Disease Journal,
29(6):535–539, June 2010.
27. Stansell, J.D., D.H. Osmond, E.
Charlebois, E., et al., ‘‘Predictors of
Pneumocystis carinii Pneumonia in HIVInfected Persons. Pulmonary
Complications of HIV Infection Study
Group,’’ American Journal of Respiratory
and Critical Care Medicine, 155(1):60–
66, January 1997.
28. Wasserman, S., M.E. Engel, M.
Mendelson, ‘‘Burden of Pneumocystis
Pneumonia in HIV-Infected Adults in
Sub-Saharan Africa: Protocol for a
Systematic Review,’’ Systematic
Reviews, 2:112, December 12, 2013.
29. Fisk, D.T., S. Meshnick, S., and P.H.
Kazanjian, ‘‘Pneumocystis carinii
Pneumonia in Patients in the Developing
World Who Have Acquired
Immunodeficiency Syndrome,’’ Clinical
Infectious Diseases: An Official
Publication of the Infectious Diseases
Society of America, 36(1):70–78, January
1, 2003.
30. de Boer, M.G., J.W. de Fijter, F.P. Kroon,
‘‘Outbreaks and Clustering of
Pneumocystis Pneumonia in Kidney
Transplant Recipients: A Systematic
Review,’’ Medical Mycology, 49(7):673–
680, October 2011.
31. Sonego, M., M.C. Pellegrin, G. Becker, et
al., ‘‘Risk Factors for Mortality from
Acute Lower Respiratory Infections
(ALRI) in Children under Five Years of
Age in Low and Middle-Income
Countries: A Systematic Review and
Meta-Analysis of Observational Studies,’’
PLOS One, 10(1):e0116380, 2015.
32. Morris, A., J.D. Lundgren, H. Masur, et
al., ‘‘Current Epidemiology of
Pneumocystis Pneumonia,’’ Emerging
Infectious Diseases, 10(10):1713–1720,
October 2004.
33. Avino, L.J., S.M. Naylor, A.M. Roecker,
‘‘Pneumocystis jirovecii Pneumonia in
the Non-HIV-Infected Population,’’ The
Annals of Pharmacotherapy, 50(8):673–
679, August 2016.
34. Joint United Nations Programme on HIV/
AIDS (UNAIDS), ‘‘Global Report:
UNAIDS Report on the Global AIDS
Epidemic 2013,’’ accessed December 9,
2016, available at https://files.unaids.org/
en/media/unaids/contentassets/
documents/epidemiology/2013/gr2013/
UNAIDS_Global_Report_2013_en.pdf.
35. WHO, ‘‘Neglected Tropical Diseases,’’
accessed December 9, 2016, available at
https://www.who.int/neglected_diseases/
diseases/en/.
Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18313 Filed 8–23–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:17 Aug 23, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–P–0964 and FDA–
2018–P–0967]
Determination That PLASMA–LYTE M
AND DEXTROSE 5% and PLASMA
LYTE 148 AND DEXTROSE 5% Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PLASMA–LYTE M
AND DEXTROSE 5% (calcium chloride,
37 milligrams (mg)/100 milliliters (mL);
dextrose, 5 grams (g)/100 mL;
magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE
5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium
chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
these products as long as they meet
relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Heather A. Dorsey, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
42899
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
PLASMA–LYTE M AND DEXTROSE
5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium
acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) is the subject of NDA
017390, held by Baxter Healthcare
Corp., and initially approved on
February 1, 1979. PLASMA LYTE 148
AND DEXTROSE 5% (dextrose, 5 g/100
mL; magnesium chloride, 30 mg/100
mL; potassium chloride, 37 mg/100 mL;
sodium acetate, 368 mg/100 mL; sodium
chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) is the
subject of NDA 017451, held by Baxter
Healthcare Corp., and initially approved
on February 2, 1979. PLASMA LYTE M
AND DEXTROSE 5% is indicated as a
source of water, electrolytes, and
calories or as an alkalinizing agent.
PLASMA LYTE 148 AND DEXTROSE
5% is indicated as a source of water,
electrolytes, and calories, or as an
alkalinizing agent.
PLASMA–LYTE M AND DEXTROSE
5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium
acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE
E:\FR\FM\24AUN1.SGM
24AUN1
daltland on DSKBBV9HB2PROD with NOTICES
42900
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium
chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) are currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In the Federal Register of October
13, 2015 (80 FR 61426), FDA announced
that it was withdrawing approval of
NDAs 017390 and 017451, effective
November 12, 2015.
Fresenius Kabi USA, LLC, submitted
two citizen petitions dated March 2,
2018 (Docket No. FDA–2018–P–0964),
and March 5, 2018 (Docket No. FDA–
2018–P–0967), under 21 CFR 10.30,
requesting that the Agency determine
whether PLASMA–LYTE M AND
DEXTROSE 5% (calcium chloride, 37
mg/100 mL; dextrose, 5 g/100 mL;
magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE
5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium
chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PLASMA–LYTE M AND
DEXTROSE
5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium
acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE 5% (dextrose, 5 g/
100 mL; magnesium chloride, 30 mg/
100 mL; potassium chloride, 37 mg/100
mL; sodium acetate, 368 mg/100 mL;
sodium chloride, 526 mg/100 mL;
sodium gluconate, 502 mg/100 mL)
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that these drug
products were withdrawn for reasons of
safety or effectiveness.
We have carefully reviewed our files
for records concerning the withdrawal
of PLASMA–LYTE M AND DEXTROSE
5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium
acetate, 161 mg/100 mL; sodium
VerDate Sep<11>2014
19:17 Aug 23, 2018
Jkt 244001
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE 5% (dextrose, 5 g/
100 mL; magnesium chloride, 30 mg/
100 mL; potassium chloride, 37 mg/100
mL; sodium acetate, 368 mg/100 mL;
sodium chloride, 526 mg/100 mL;
sodium gluconate, 502 mg/100 mL) from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that these
drug products were not withdrawn from
sale for reasons of safety or
effectiveness.
Accordingly, the Agency will
continue to list PLASMA–LYTE M AND
DEXTROSE 5% (calcium chloride, 37
mg/100 mL; dextrose, 5 g/100 mL;
magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE
5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium
chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium
chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) 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. ANDAs that refer
to these drug products may 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 these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18311 Filed 8–23–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0101]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
User Fee Cover Sheet; Form FDA 3397
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements relating to the
Prescription Drug User Fee Cover Sheet,
Form FDA 3397, that must be submitted
along with certain drug and biological
product applications.
DATES: Submit either electronic or
written comments on the collection of
information by October 23, 2018.
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 October 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 23, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42899-42900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18311]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-P-0964 and FDA-2018-P-0967]
Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE
148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37
milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL;
magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium
lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose,
5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37
mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100
mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to these products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) is the subject
of NDA 017390, held by Baxter Healthcare Corp., and initially approved
on February 1, 1979. PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100
mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL;
sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) is the subject of NDA 017451, held by Baxter
Healthcare Corp., and initially approved on February 2, 1979. PLASMA
LYTE M AND DEXTROSE 5% is indicated as a source of water, electrolytes,
and calories or as an alkalinizing agent. PLASMA LYTE 148 AND DEXTROSE
5% is indicated as a source of water, electrolytes, and calories, or as
an alkalinizing agent.
PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE
[[Page 42900]]
5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium
chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride,
526 mg/100 mL; sodium gluconate, 502 mg/100 mL) are currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book. In
the Federal Register of October 13, 2015 (80 FR 61426), FDA announced
that it was withdrawing approval of NDAs 017390 and 017451, effective
November 12, 2015.
Fresenius Kabi USA, LLC, submitted two citizen petitions dated
March 2, 2018 (Docket No. FDA-2018-P-0964), and March 5, 2018 (Docket
No. FDA-2018-P-0967), under 21 CFR 10.30, requesting that the Agency
determine whether PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37
mg/100 mL; dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL;
sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and
PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) were withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that PLASMA-LYTE M AND DEXTROSE 5%
(calcium chloride, 37 mg/100 mL; dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium
acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100
mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL;
sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that these drug products were withdrawn for
reasons of safety or effectiveness.
We have carefully reviewed our files for records concerning the
withdrawal of PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/
100 mL; dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL;
sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and
PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that these drug products were not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list PLASMA-LYTE M AND
DEXTROSE 5% (calcium chloride, 37 mg/100 mL; dextrose, 5 g/100 mL;
magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium
lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose,
5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37
mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100
mL; sodium gluconate, 502 mg/100 mL) 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. ANDAs that refer to these drug products may 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 these drug products should be revised to meet current standards,
the Agency will advise ANDA applicants to submit such labeling.
Dated: August 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18311 Filed 8-23-18; 8:45 am]
BILLING CODE 4164-01-P
