Document ID: FDA-2022-N-2391-0001
Agency: fda
Document Type: Notice
Title: Miles Laboratories Inc.; Proposal To Withdraw Approval of an Abbreviated
New Drug Application for Alcohol and Dextrose Injection; 5 Milliliters/100
Milliliters, 5 Grams/100 Milliliters; Opportunity for a Hearing
Posted Date: 2022-10-24T04:00Z

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64227-64229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2391]

Miles Laboratories Inc.; Proposal To Withdraw Approval of an 
Abbreviated New Drug Application for Alcohol and Dextrose Injection; 5 
Milliliters/100 Milliliters, 5 Grams/100 Milliliters; Opportunity for a 
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is proposing to withdraw approval 
of an abbreviated new drug application (ANDA) for Alcohol and Dextrose 
Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/100 mL, and is 
announcing an opportunity for the ANDA holder to request a hearing on 
this proposal: Miles Laboratories Inc., P.O. Box 1986, 4th and Parker 
St., Berkeley, CA 94701, is the last holder of record. The bases for 
the proposal 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: The ANDA holder may submit a request for a hearing by November 
23, 2022. Submit all data, information, and analyses upon which the 
request for a hearing relies by December 23, 2022. Submit electronic or 
written comments by December 23, 2022.

ADDRESSES: The request for a hearing may be submitted by the ANDA 
holder by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request does not 
include any confidential information that you or a third party may not 
wish to be posted, such as medical information, your or anyone else's 
Social Security number, or confidential business information, such as a 
manufacturing process. The request for a hearing must include the 
Docket No. FDA-2022-N-2391 for ``Miles Laboratories Inc.; Proposal To 
Withdraw Approval of an Abbreviated New Drug Application for Alcohol 
and Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100 
Milliliters; Opportunity for a Hearing.'' The request for a hearing 
will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    The ANDA holder may submit all data and analyses upon which the 
request for a hearing relies in the same manner as the request for a 
hearing except as follows:
     Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
any decisions on this matter. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday, 240-402-7500. Submit both copies to the Dockets 
Management Staff. Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that

[[Page 64228]]

identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-N-2391 for ``Miles Laboratories Inc.; Proposal To Withdraw 
Approval of an Abbreviated New Drug Application for Alcohol and 
Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100 
Milliliters; Opportunity for a Hearing.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 and other applicable 
disclosure law. For more information about FDA's posting of comments to 
public dockets, see 80 FR 56469, September 18, 2015, or access the 
information at https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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.

SUPPLEMENTARY INFORMATION: On November 22, 1974, FDA approved ANDA 
083483 for Alcohol and Dextrose Injection. In a letter dated June 23, 
1999, Bayer Corporation, which had at least partially acquired Miles 
Laboratories Inc., notified FDA that Alcohol and Dextrose Injection, 5 
mL/100 mL, 5 g/100 mL, the subject of ANDA 083483, was no longer 
marketed, and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' FDA has not received information specified in 21 CFR 314.72 to 
change the ownership of ANDA 083483, although Miles Laboratories Inc. 
does not appear to be separately manufacturing drug products. The 
Agency is therefore identifying Miles Laboratories Inc. as the ANDA 
holder of record in this Federal Register notice, but in the event that 
another entity holds ANDA 083483, the Agency is also providing notice 
to that entity.
    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). 
Because the holder of ANDA 083483 for Alcohol and Dextrose Injection, 5 
mL/100 mL, 5 g/100 mL, has repeatedly failed to submit the required 
annual reports, FDA proposes to withdraw approval of ANDA 083483 under 
Sec.  314.150(b)(1) (21 CFR 314.150(b)(1)).
    Additionally, under 21 CFR 314.161, FDA has 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 NDA 004589). In light of 
our determination, FDA proposes to withdraw approval of ANDA 083483 
under Sec.  314.150(a)(2)(i) because the Agency has scientific data and 
experience to show that 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.
    As explained in our Federal Register notice determining that 
Alcohol and Dextrose was withdrawn 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. Today, 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.
    Therefore, notice is given to the ANDA holder and to all other 
interested persons that the Director of CDER proposes to issue an 
order, under section 505(e)(2) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 355(e)(2)), withdrawing approval of ANDA 
083483 and all amendments and supplements thereto on the grounds 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 FD&C Act, and 
(2) the Agency has scientific data and experience to show that 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 accordance with section 505(e) of the FD&C Act and Sec. Sec.  
314.150(a)(2)(i) and (b)(1) and Sec.  314.200 (21 CFR 314.200), the 
ANDA holder is hereby provided an opportunity for a hearing to show why 
the approval of ANDA 083483 should not be withdrawn and an opportunity 
to raise, for administrative determination, all issues relating to the

[[Page 64229]]

legal status of the drug product covered by ANDA 083483.
    An ANDA holder who decides to seek a hearing must file the 
following: (1) a written notice of participation and request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to demonstrate that there is a genuine and 
substantial issue of fact that requires a hearing (see DATES and 
ADDRESSES). Any other interested person may also submit comments on 
this notice. The procedures and requirements governing this notice of 
opportunity for a hearing, notice of participation and request for a 
hearing, the information and analyses to justify a hearing, other 
comments, and a grant or denial of a hearing are contained in Sec.  
314.200 and in 21 CFR part 12.
    The failure of an ANDA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that ANDA holder not to avail itself of the 
opportunity for a hearing concerning CDER's proposal to withdraw 
approval of the ANDA and constitutes a waiver of any contentions 
concerning the legal status of the drug product. FDA will then withdraw 
approval of the ANDA, and the drug product may not thereafter be 
lawfully introduced or delivered for introduction into interstate 
commerce. Any new drug product introduced or delivered for introduction 
into interstate commerce without an approved ANDA is subject to 
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials but must present specific facts showing that there is a genuine 
and substantial issue of fact that requires a hearing (Sec.  
314.200(g)). If a request for a hearing is not complete or is not 
supported, the Commissioner of Food and Drugs will enter summary 
judgment against the person who requests the hearing, making findings 
and conclusions, and denying a hearing (Sec.  314.200(g)(1)).
    All submissions under this notice of opportunity for a hearing must 
be filed in two copies. Except for data and information prohibited from 
public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the 
submissions may be seen at the Dockets Management Staff (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: October 14, 2022.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2022-23034 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P