Determination That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27901-27902 [2023-09365]
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Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Notices
3606(a)(1) of the Food and Drug
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for any person and is not binding on
VerDate Sep<11>2014
18:32 May 02, 2023
Jkt 259001
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www.regulations.gov.
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09399 Filed 5–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–2060]
Determination That Levitra (Vardenafil
Hydrochloride) Oral Tablets, 5
Milligrams, 10 Milligrams, and 20
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that Levitra (vardenafil
hydrochloride) oral tablets, 5 milligrams
(mg), 10 mg, and 20 mg, were not
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
27901
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
these products as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Daniel Ritterbeck, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002, 301–
796–4673, Daniel.Ritterbeck@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Levitra (vardenafil hydrochloride)
oral tablets, 5 mg, 10 mg and 20 mg, are
E:\FR\FM\03MYN1.SGM
03MYN1
lotter on DSK11XQN23PROD with NOTICES1
27902
Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Notices
the subject of NDA 021400, held by
Bayer HealthCare Pharmaceuticals, Inc.,
and initially approved on August 19,
2003. Levitra is a phosphodiesterase 5
inhibitor indicated for the treatment of
erectile dysfunction.
In letters dated September 26, 2019,
September 24, 2020, and September 20,
2021, Bayer HealthCare
Pharmaceuticals, Inc. notified FDA that
Levitra (vardenafil hydrochloride) oral
tablets, 5 mg, 10 mg and 20 mg,
respectively, were being discontinued,
and FDA moved the drug products to
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Respira Therapeutics, Inc. submitted a
citizen petition dated August 29, 2022
(Docket No. FDA–2022–P–2060), under
21 CFR 10.30, requesting that the
Agency determine whether Levitra
(vardenafil hydrochloride) oral tablets,
20 mg, were withdrawn from sale for
reasons of safety or effectiveness.
Although the citizen petition did not
address the 5 mg and 10 mg strengths,
those strengths have also been
discontinued. On our own initiative, we
have also determined whether those
strengths were withdrawn for safety or
effectiveness reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that Levitra (vardenafil
hydrochloride) oral tablets, 5 mg, 10 mg,
and 20 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that these drug
products were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of Levitra
(vardenafil hydrochloride) oral tablets, 5
mg, 10 mg, and 20 mg, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list Levitra (vardenafil
hydrochloride) oral tablets, 5 mg, 10 mg,
and 20 mg, 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. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to these drug products. Additional
ANDAs for these drug products may
also be approved by the Agency as long
VerDate Sep<11>2014
18:32 May 02, 2023
Jkt 259001
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09365 Filed 5–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection; Public
Comment Request; Application and
Other Forms Used by the National
Health Service Corps Scholarship
Program, the NHSC Students to
Service Loan Repayment Program, and
the Native Hawaiian Health
Scholarship Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
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Comments on this ICR should be
received no later than June 2, 2023.
ADDRESSES: Written comments and
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notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments,’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the Acting HRSA
Information Collection Clearance
Officer, at paperwork@hrsa.gov or call
301–594–4394.
DATES:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Application and Other Forms Used by
the National Health Service Corps
(NHSC) Scholarship Program (SP), the
NHSC Students to Service Loan
Repayment Program (S2S LRP), and the
Native Hawaiian Health Scholarship
Program (NHHSP), OMB No. 0915–
0146-Revision.
Abstract: Administered by HRSA’s
Bureau of Health Workforce, the NHSC
SP, NHSC S2S LRP, and the NHHSP
provide scholarships or loan repayment
to qualified students who are pursuing
primary care health professions
education and training. In return,
students agree to provide primary health
care services in underserved
communities located in federally
designated Health Professional Shortage
Areas once they are fully trained and
licensed health professionals. Awards
are made to applicants who demonstrate
the greatest potential for successful
completion of their education and
training as well as commitment to
provide primary health care services to
communities of greatest need. The
information from program applications,
forms, and supporting documentation is
used to select the best qualified
candidates for these competitive
awards, and to monitor program
participants’ enrollment in school,
postgraduate training, and compliance
with program requirements.
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from program to program (see programspecific burden charts below), required
forms generally include: a program
application, academic and nonacademic letters of recommendation, the
authorization to release information,
and the acceptance/verification of good
academic standing report. The NHHSP
is not seeking to change or add any
forms or documentation.
A 60-day notice published in the
Federal Register on February 14, 2023,
88 FR 9525–26. There were no public
comments.
Need and Proposed Use of the
Information: The NHSC SP, S2S LRP,
and NHHSP applications, forms, and
supporting documentation are used to
collect necessary information from
applicants and schools that enable
HRSA to make selection determinations
for the competitive awards and monitor
compliance (via training programs and
sites) with program requirements.
Likely Respondents: Qualified
students who are pursuing education
and training in primary care health
professions and are interested in
working in health professional shortage
areas and schools at which such
students are enrolled.
E:\FR\FM\03MYN1.SGM
03MYN1
]]>Agencies
[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27901-27902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-2060]
Determination That Levitra (Vardenafil Hydrochloride) Oral
Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Levitra (vardenafil hydrochloride) oral tablets, 5
milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to these products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Daniel Ritterbeck, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-4673, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20
mg, are
[[Page 27902]]
the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals,
Inc., and initially approved on August 19, 2003. Levitra is a
phosphodiesterase 5 inhibitor indicated for the treatment of erectile
dysfunction.
In letters dated September 26, 2019, September 24, 2020, and
September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc. notified FDA
that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and
20 mg, respectively, were being discontinued, and FDA moved the drug
products to the ``Discontinued Drug Product List'' section of the
Orange Book.
Respira Therapeutics, Inc. submitted a citizen petition dated
August 29, 2022 (Docket No. FDA-2022-P-2060), under 21 CFR 10.30,
requesting that the Agency determine whether Levitra (vardenafil
hydrochloride) oral tablets, 20 mg, were withdrawn from sale for
reasons of safety or effectiveness. Although the citizen petition did
not address the 5 mg and 10 mg strengths, those strengths have also
been discontinued. On our own initiative, we have also determined
whether those strengths were withdrawn for safety or effectiveness
reasons.
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 Levitra (vardenafil hydrochloride) oral
tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that these drug products were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of Levitra (vardenafil
hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that these drug products were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list Levitra (vardenafil
hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, 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. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to these drug products.
Additional ANDAs for these drug products may also 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 these
drug products should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09365 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P
