[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Page 37954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13593]



[[Page 37954]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-0678]


Determination That DEXTROSE IN PLASTIC CONTAINER (Dextrose) 
Injectable, 30 Grams/100 Milliliters, 40 Grams/100 Milliliters, 60 
Grams/100 Milliliters, and 70 Grams/100 Milliliters, Were Not Withdrawn 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 DEXTROSE IN PLASTIC CONTAINER (dextrose) injectable, 30 
grams (g)/100 milliliters (mL), 40 g/100 mL, 60 g/100 mL, and 70 g/100 
mL, were not withdrawn from sale for reasons of safety or 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 injectable, 30 g/100 mL, 40 
g/100 mL, 60 g/100 mL, and 70 g/100 mL, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6258, Silver Spring, MD 20993-0002, 301-
796-8767, [email protected].

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 IN PLASTIC CONTAINER (dextrose) injectable, 30 g/100 mL, 
40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, are the subject of NDA 
017521, held by Baxter Healthcare Corporation, and initially approved 
on August 28, 1979. DEXTROSE IN PLASTIC CONTAINER is indicated as a 
source of calories for patients requiring parenteral nutrition when 
oral or enteral nutrition is not possible, insufficient or 
contraindicated. DEXTROSE IN PLASTIC CONTAINER (dextrose) injectable, 
30 g/100 mL, 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, are currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Fresenius Kabi USA, LLC, submitted a citizen petition dated 
February 6, 2020 (Docket No. FDA-2020-P-0678), under 21 CFR 10.30, 
requesting that the Agency determine whether DEXTROSE 70% IN PLASTIC 
CONTAINER (dextrose) injectable, 70 g/100 mL, was withdrawn from sale 
for reasons of safety or effectiveness. Although the citizen petition 
did not address the 30 g/100 mL, 40 g/100 mL, or 60 g/100 mL strengths, 
those strengths have also been discontinued. On our own initiative, we 
have also determined whether those strengths were withdrawn for safety 
or effectiveness reasons.
    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 IN PLASTIC CONTAINER (dextrose) 
injectable, 30 g/100 mL, 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, 
were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
DEXTROSE IN PLASTIC CONTAINER (dextrose) injectable, 30 g/100 mL, 40 g/
100 mL, 60 g/100 mL, and 70 g/100 mL, were withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of DEXTROSE IN PLASTIC CONTAINER 
(dextrose) injectable, 30 g/100 mL, 40 g/100 mL, 60 g/100 mL, and 70 g/
100 mL, 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 DEXTROSE IN PLASTIC 
CONTAINER (dextrose) injectable, 30 g/100 mL, 40 g/100 mL, 60 g/100 mL, 
and 70 g/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 DEXTROSE IN PLASTIC CONTAINER (dextrose) injectable, 30 g/100 
mL, 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, 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: June 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13593 Filed 6-23-20; 8:45 am]
BILLING CODE 4164-01-P