[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43143-43144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17874]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0466]


Determination That Dextrose, 20 Grams/100 Milliliters, and 
Dextrose, 50 Grams/100 Milliliters, in Plastic Containers, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 Dextrose, 20 grams (g)/100 milliliters (mL), and 
Dextrose, 50 g/100 mL, in plastic containers, were not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic 
containers, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
348-3946, Heather.Dorsey@fda.hhs.gov.

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.
    Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic 
containers, are the subject of NDA 017521, held by Baxter Healthcare 
Corporation and initially approved on August 28, 1979. Dextrose, 20 g/
100 mL, and Dextrose, 50 g/100 mL, in plastic containers, are indicated 
as a source of calories when mixed with amino acids or other compatible 
intravenous fluids for patients requiring parenteral nutrition when 
oral or enteral nutrition is not

[[Page 43144]]

possible, insufficient, or contraindicated.
    Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic 
containers (NDA 017521), are currently listed in the ``Discontinued 
Drug Product List'' section of the Orange Book.
    Fresenius Kabi USA, LLC, submitted a citizen petition dated January 
29, 2019 (Docket No. FDA-2019-P-0466), under 21 CFR 10.30, requesting 
that the Agency determine whether Dextrose, 20 g/100 mL, and Dextrose, 
50 g/100 mL, in plastic containers (NDA 017521), were 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 Sec.  314.161 that Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 
mL, in plastic containers (NDA 017521), were not withdrawn for reasons 
of safety or effectiveness. The petitioner has identified no data or 
other information suggesting that Dextrose, 20 g/100 mL, and Dextrose, 
50 g/100 mL, in plastic containers, were withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of Dextrose, 20 g/100 mL, and 
Dextrose, 50 g/100 mL, in plastic containers, 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 these drug products were withdrawn from sale for reasons 
of safety or effectiveness.
    Accordingly, the Agency will continue to list Dextrose, 20 g/100 
mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), 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 Dextrose, 20 g/100 
mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), 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 this drug product should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17874 Filed 8-19-19; 8:45 am]
 BILLING CODE 4164-01-P


