[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10343-10344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03367]


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

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.

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

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DATES: Approval is withdrawn as of February 17, 2023.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, [email protected].

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mL, approved under ANDA 083483 was withdrawn from sale for safety and 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Register notice determining that Alcohol and Dextrose was withdrawn 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