[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]
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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148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety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.
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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mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for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