Determination That LEVITRA (Vardenafil Hydrochloride) Tablets, 2.5 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 39855-39856 [2019-17212]
Download as PDF
<![CDATA[
39855
Federal Register / Vol. 84, No. 155 / Monday, August 12, 2019 / Notices
• The Revised Instrument and
Instructions will include a chart for the
financial plan and a chart for the
existing centers that specifies what
counties they serve, what entities
oversee them, and what oversight
processes apply.
• The Revised Instrument will
include a signatures section.
These revisions were recommended
by the technical assistance provider and
analyzed by all the independent living
program officers who work directly with
SPILs.
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Respondent/data
collection activity
Responses
per
respondent
Hours per
response
Annual
burden
hours
Statewide Independent Living Councils ..........................................................
56
1
240
13,440
Total ..........................................................................................................
56
1
240
13,440
Dated: August 6, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–17172 Filed 8–9–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–2290]
Determination That LEVITRA
(Vardenafil Hydrochloride) Tablets, 2.5
Milligrams Were Not Withdrawn From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) tablets, 2.5 milligrams
(mg), were not withdrawn from sale for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 this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Daniel J. 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: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
SUMMARY:
jspears on DSK3GMQ082PROD with NOTICES
Number of
respondents
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
56 SILCs will respond to the
requirement for a SPIL every three
years. Each state’s SILC will take
approximately 240 hours to develop the
SPIL for a total of approximately 13,440
hours. This estimate is based on
program knowledge.
VerDate Sep<11>2014
17:16 Aug 09, 2019
Jkt 247001
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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)
tablets, 2.5 mg, are the subject of NDA
021400, held by Bayer HealthCare
Pharmaceuticals, Inc., and initially
approved on August 19, 2003. LEVITRA
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
is a phosphodiesterase 5 (PDE5)
inhibitor indicated for the treatment of
erectile dysfunction. LEVITRA
(vardenafil hydrochloride) tablets, 2.5
mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
In a letter dated March 22, 2018,
Bayer HealthCare Pharmaceuticals, Inc.,
notified FDA that LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Alembic Pharmaceuticals Limited
submitted a citizen petition received on
May 9, 2019 (Docket No. FDA–2019–P–
2290), under 21 CFR 10.30, requesting
that the Agency determine whether
LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg, were withdrawn from
sale for safety or effectiveness reasons
and permit the filing of abbreviated new
drug applications (ANDAs) referencing
LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg.
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) tablets, 2.5 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of LEVITRA
(vardenafil hydrochloride) tablets, 2.5
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 this drug product was
E:\FR\FM\12AUN1.SGM
12AUN1
39856
Federal Register / Vol. 84, No. 155 / Monday, August 12, 2019 / Notices
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list LEVITRA (vardenafil
hydrochloride) tablets, 2.5 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 this
drug product. Additional ANDAs for
this drug product 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 this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17212 Filed 8–9–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3453]
Promoting Effective Drug Development
Programs: Opportunities and Priorities
for the Food and Drug Administration’s
Office of New Drugs; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is holding a public meeting on
November 7, 2019 entitled ‘‘Promoting
Effective Drug Development Programs:
Opportunities and Priorities for FDA’s
Office of New Drugs.’’ The purpose of
the public meeting is to solicit specific,
actionable policy suggestions that could
be implemented in the near-term by the
review staff of the Center for Drug
Evaluation and Research’s (CDER’s)
Office of New Drugs to promote
effective drug development programs
without compromising our regulatory
standards for the assessment of safety
and effectiveness.
DATES: The public meeting will be held
on November 7, 2019, from 9 a.m. to 5
p.m. The public meeting may be
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:16 Aug 09, 2019
Jkt 247001
extended or may end early depending
on the level of public participation.
Persons can attend the event in-person
or via webcast. In-person attendees can
also request to give a formal
presentation as part of the registration
process. See the SUPPLEMENTARY
INFORMATION section for registration date
and information. Electronic or written
comments will be accepted after the
public hearing until January 7, 2020.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Entrance for public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before January 7, 2020. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of January 7, 2020. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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–
2019–N–3453 for ‘‘Promoting Effective
Drug Development Programs:
Opportunities and Priorities for FDA’s
Office of New Drugs.’’ 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.
• 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 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.gpo.gov/
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Notices]
[Pages 39855-39856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17212]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-2290]
Determination That LEVITRA (Vardenafil Hydrochloride) Tablets,
2.5 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) tablets, 2.5
milligrams (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 this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Daniel J. 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: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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) tablets, 2.5 mg, are the subject
of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and
initially approved on August 19, 2003. LEVITRA is a phosphodiesterase 5
(PDE5) inhibitor indicated for the treatment of erectile dysfunction.
LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
In a letter dated March 22, 2018, Bayer HealthCare Pharmaceuticals,
Inc., notified FDA that LEVITRA (vardenafil hydrochloride) tablets, 2.5
mg, were being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Alembic Pharmaceuticals Limited submitted a citizen petition
received on May 9, 2019 (Docket No. FDA-2019-P-2290), under 21 CFR
10.30, requesting that the Agency determine whether LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were withdrawn from sale for safety or
effectiveness reasons and permit the filing of abbreviated new drug
applications (ANDAs) referencing LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg.
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) tablets,
2.5 mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of LEVITRA (vardenafil
hydrochloride) tablets, 2.5 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 this drug product was
[[Page 39856]]
not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list LEVITRA (vardenafil
hydrochloride) tablets, 2.5 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 this drug product. Additional ANDAs for
this drug product 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 this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17212 Filed 8-9-19; 8:45 am]
BILLING CODE 4164-01-P
