[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Grams/100 Milliliters, and 70 Grams/100 Milliliters, Were Not Withdrawn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mL, were not withdrawn from sale for reasons of safety or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