Notice2023-03367
Miles Laboratories Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Alcohol and Dextrose Injection; 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/ 100 mL. The bases for the withdrawal are that the ANDA holder has repeatedly failed to file required annual reports for this ANDA and that the Agency has scientific data and experience to show that the drug product under this ANDA is unsafe for use under the conditions of use for which the product was approved.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10343-10344]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03367]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2391]
Miles Laboratories Inc.; Withdrawal of Approval of an Abbreviated
New Drug Application for Alcohol and Dextrose Injection; 5 Milliliters/
100 Milliliters, 5 Grams/100 Milliliters
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of an abbreviated new drug application (ANDA) for
Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/
100 mL. The bases for the withdrawal are that the ANDA holder has
repeatedly failed to file required annual reports for this ANDA and
that the Agency has scientific data and experience to show that the
drug product under this ANDA is unsafe for use under the conditions of
use for which the product was approved.
DATES: Approval is withdrawn as of February 17, 2023.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1546, <a href="/cdn-cgi/l/email-protection#d49fb5b1a0bbb7bcbdfa9bbfb1b9b3b6bb94b2b0b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="cd86aca8b9a2aea5a4e382a6a8a0aaafa28daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The holder of an approved ANDA to market a
new drug for human use is required to submit annual reports to FDA
concerning its approved ANDA under Sec. Sec. 314.81 and 314.98 (21 CFR
314.81 and 314.98). Additionally, under 21 CFR 314.161, FDA previously
determined that Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100
mL, approved under ANDA 083483 was withdrawn from sale for safety and
effectiveness reasons (see 86 FR 72606, December 22, 2021) (this
determination also applied to other applications and to the 10 mL/100
mL, 5 g/100 mL strength of Alcohol and Dextrose Injection approved
under new drug application (NDA) 004589). As explained in our Federal
Register notice determining that Alcohol and Dextrose was withdrawn
from sale for safety and effectiveness reasons, Alcohol and Dextrose
Injection is indicated to provide increased caloric intake. The use of
Alcohol and Dextrose raises several safety concerns because there are
many risks associated with the exposure to alcohol. Alcohol is
contraindicated for use in patients with neurologic disorders, such as
seizures, who have current or past substance abuse problems, or who are
pregnant. It can cause intoxication, respiratory depression, and
disturbances in serum glucose levels. FDA-approved alternatives for
intravenous calorie supplementation that do not include alcohol were
approved after these Alcohol and Dextrose products and are available
today.
In the Federal Register of October 24, 2022 (87 FR 64227), FDA
published a notice of opportunity for a hearing (NOOH) on a proposal to
withdraw approval of ANDA 083483, held by Miles Laboratories Inc., the
last holder of record, under Sec. 314.150(b)(1) (21 CFR 314.150(b)(1))
because the ANDA holder has repeatedly failed to submit the required
annual reports and under Sec. 314.150(a)(2)(i) because the Agency has
scientific data and experience to show that the drug product approved
under ANDA 083483, Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100
mL, is unsafe for use under the conditions of use for which the product
was approved. The ANDA holder did not respond to the NOOH. Failure to
file a written notice of participation and request for hearing as
required by Sec. 314.200 (21 CFR 314.200) constitutes a waiver of the
opportunity for a hearing by the ANDA holder concerning the proposal to
withdraw approval of the ANDA and a waiver of any contentions
concerning the legal status of the drug product. Accordingly, FDA is
withdrawing approval of ANDA 083483.
Therefore, for reasons discussed above, FDA finds that: (1) the
ANDA holder has failed to submit reports required under Sec. Sec.
314.81 and 314.98 and section 505(k) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(k)) and (2) the Agency has
scientific data and experience to show that the drug product approved
under ANDA 083483, Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100
mL, is unsafe for use under the conditions of use for which the product
was approved. In addition, under Sec. 314.200, FDA finds that the ANDA
holder has waived its opportunity for a hearing and any contentions
concerning the legal status of the drug products. Therefore, based on
these findings and pursuant to the authority under section 505(e) of
the FD&C Act, approval of ANDA 083483 and all amendments and
supplements thereto is hereby withdrawn as of February 17, 2023.
[[Page 10344]]
Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03367 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P
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