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148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety 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mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for 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