Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP, 83883-83884 [2024-24106]
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Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, EXXUA (gepirone
hydrochloride) indicated for treatment
of major depressive disorder in adults.
Subsequent to this approval, the USPTO
received a patent term restoration
application for EXXUA (U.S. Patent No.
7,538,116) from Fabre-Kramer
Pharmaceuticals, Inc. and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
February 6, 2024, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of EXXUA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
EXXUA is 14,390 days. Of this time,
6,226 days occurred during the testing
phase of the regulatory review period,
while 8,164 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: May 2, 1984.
Fabre-Kramer Pharmaceuticals, Inc.
claims that October 1, 1989, is the date
the investigational new drug application
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16:48 Oct 17, 2024
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83883
(IND) became effective. However, FDA’s
records indicate that the effective date
of an earlier IND was May 2, 1984,
which was 30 days after FDA received
the earlier IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: May 18, 2001. The
applicant claims July 19, 1999, as the
date the new drug application (NDA) for
EXXUA (NDA 21164) was initially
submitted. However, FDA records
indicate that NDA 21164, submitted on
October 1, 1999, was incomplete. FDA
refused the application and notified the
applicant of this fact by letter dated
November 30, 1999. The complete NDA
was then submitted on May 18, 2001,
which is considered to be the initially
submitted date.
3. The date the application was
approved: September 22, 2023 5:47:00
p.m. FDA has verified the applicant’s
claim that NDA 21164 was approved on
September 22, 2023.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
Dated: October 10, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
DATES:
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[FR Doc. 2024–24109 Filed 10–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4560]
Linde, Inc.; Withdrawal of Approval of
a New Drug Application and New
Animal Drug Application for Helium,
USP
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) 205851 and the new
animal drug application (NADA) 141–
389 for the designated medical gas
Helium, USP held by Linde, Inc., 175
East Park Dr., Tonawanda, NY 14150–
7844. Linde, Inc. notified the Agency in
writing that the drug product was no
longer marketed and requested that the
approval of the application be
withdrawn.
SUMMARY:
Approval is withdrawn as of
November 18, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov; or Scott Fontana (HFV–
180), Center for Veterinary Medicine,
Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240–
402–0656, Scott.Fontana@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
12, 2024, Linde, Inc. informed FDA that
it is no longer marketing the designated
medical gas Helium, USP and requested
that FDA withdraw approval of NDA
205851 and NADA 141–389 under the
processes in § 314.150(c) (21 CFR
314.150(c)) and § 514.115(d) (21 CFR
514.115(d)). Linde, Inc. has also, by its
request, waived its opportunity for a
hearing. Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) or an NADA or
abbreviated new animal drug
application under § 514.115(d) is
without prejudice to refiling.
Therefore, approval of NDA 205851
and NADA 141–389, and all
amendments and supplements thereto,
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Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
are hereby withdrawn as of November
18, 2024. Introduction or delivery for
introduction into interstate commerce of
Helium, USP, without an approved new
drug application or an approved new
animal drug application violates
sections 505(a), 512(a), 301(a), and
301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a),
360b(a)(1), 331(a), and 331(d)). Any
Helium, USP manufactured by Linde,
Inc. pursuant to these applications that
is in inventory on November 18, 2024
may continue to be dispensed until the
inventories have been depleted or the
drug product has reached its expiration
date or otherwise become violative,
whichever occurs first.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24106 Filed 10–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2303]
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Core
Patient-Reported Outcomes in Cancer
Clinical Trials.’’ This final guidance
provides recommendations to sponsors
regarding the collection of a core set of
patient-reported clinical outcomes
(herein referred to as core patientreported outcomes) in cancer clinical
trials and related considerations for
instrument selection and trial design.
This final guidance focuses on patientreported outcome (PRO) measures and
is specific to registration trials for anticancer therapies intended to
demonstrate an effect on survival, tumor
response, or delay in the progression of
a malignancy.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on October 18, 2024.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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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
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
Core Patient-Reported Outcomes in
Cancer Clinical Trials; Guidance for
Industry; Availability
AGENCY:
Electronic 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–
2020–D–2303 for ‘‘Core PatientReported Outcomes in Cancer Clinical
Trials.’’ Received comments 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
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‘‘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 21 CFR 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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Vishal Bhatnagar, Oncology Center of
Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2113, Silver Spring,
MD 20993–0002, 240–402–3696; or
James Myers, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7910.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83883-83884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4560]
Linde, Inc.; Withdrawal of Approval of a New Drug Application and
New Animal Drug Application for Helium, USP
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) 205851 and the
new animal drug application (NADA) 141-389 for the designated medical
gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY
14150-7844. Linde, Inc. notified the Agency in writing that the drug
product was no longer marketed and requested that the approval of the
application be withdrawn.
DATES: Approval is withdrawn as of November 18, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected]; or Scott Fontana (HFV-180),
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0656,
[email protected].
SUPPLEMENTARY INFORMATION: On March 12, 2024, Linde, Inc. informed FDA
that it is no longer marketing the designated medical gas Helium, USP
and requested that FDA withdraw approval of NDA 205851 and NADA 141-389
under the processes in Sec. 314.150(c) (21 CFR 314.150(c)) and Sec.
514.115(d) (21 CFR 514.115(d)). Linde, Inc. has also, by its request,
waived its opportunity for a hearing. Withdrawal of approval of an
application or abbreviated application under Sec. 314.150(c) or an
NADA or abbreviated new animal drug application under Sec. 514.115(d)
is without prejudice to refiling.
Therefore, approval of NDA 205851 and NADA 141-389, and all
amendments and supplements thereto,
[[Page 83884]]
are hereby withdrawn as of November 18, 2024. Introduction or delivery
for introduction into interstate commerce of Helium, USP, without an
approved new drug application or an approved new animal drug
application violates sections 505(a), 512(a), 301(a), and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a), 360b(a)(1),
331(a), and 331(d)). Any Helium, USP manufactured by Linde, Inc.
pursuant to these applications that is in inventory on November 18,
2024 may continue to be dispensed until the inventories have been
depleted or the drug product has reached its expiration date or
otherwise become violative, whichever occurs first.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24106 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P
