[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Withdrawn From Sale for Reasons of Safety or Effectiveness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Dextrose, 50 g/100 mL, in plastic containers, were not withdrawn from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, [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, 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