Determination That CALAN SR (Verapamil Hydrochloride) Extended-Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 78606-78607 [2016-26932]
Download as PDF
<![CDATA[
78606
Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices
Ave., Bldg. 21, Rm. 3557, Silver Spring,
MD 20993–0002, 301–796–2055; or
Robert Temple, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4212,
Silver Spring, MD 20993–0002, 301–
796–2270; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘NonInferiority Clinical Trials to Establish
Effectiveness.’’ This guidance consists
of four parts. The first part is a general
discussion of regulatory, study design,
scientific, and statistical issues
associated with the use of NI studies to
establish the effectiveness of a drug or
biologic. The second part focuses on
some of these issues in more detail,
notably the statistical approaches used
to determine the NI margin and to test
for non-inferiority. The third part
addresses commonly asked questions
about NI studies. The fourth part
includes four examples of successful
and unsuccessful efforts to define NI
margins and test for non-inferiority.
This guidance finalizes the draft
guidance for industry, ‘‘Non-Inferiority
Clinical Trials,’’ published in 2010. In
addition, it supersedes the guidance for
industry, ‘‘Antibacterial Drug Products:
Use of Noninferiority Trials to Support
Approval,’’ also published in 2010,
which will be withdrawn.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on NI clinical trials to
establish effectiveness. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
mstockstill on DSK3G9T082PROD with NOTICES
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm; https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm; or
https://www.regulations.gov.
VerDate Sep<11>2014
16:27 Nov 07, 2016
Jkt 241001
Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26931 Filed 11–7–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–2674]
Determination That CALAN SR
(Verapamil Hydrochloride) ExtendedRelease Oral Tablet, 180 Milligrams,
Was 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 CALAN SR (verapamil
hydrochloride) extended-release oral
tablet, 180 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for verapamil
hydrochloride extended-release oral
tablet, 180 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363.
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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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.
CALAN SR (verapamil hydrochloride)
extended-release oral tablet, 180 mg, is
the subject of NDA 019152 held by
Pfizer Inc. CALAN SR is indicated for
the treatment of hypertension, to lower
blood pressure. CALAN SR (verapamil
hydrochloride) extended-release oral
tablet, 180 mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Heritage Pharma Labs, Inc., submitted
a citizen petition dated August 31, 2016
(Docket No. FDA–2016–P–2674), under
21 CFR 10.30, requesting that the
Agency determine whether CALAN SR
(verapamil hydrochloride) extendedrelease oral tablet, 180 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
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 CALAN SR (verapamil
hydrochloride) extended-release oral
tablet, 180 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that CALAN SR
(verapamil hydrochloride) extendedrelease oral tablet, 180 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of CALAN
SR (verapamil hydrochloride) extendedrelease oral tablet, 180 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CALAN SR (verapamil
hydrochloride) extended-release oral
E:\FR\FM\08NON1.SGM
08NON1
Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices
tablet, 180 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.
ANDAs that refer to CALAN SR
(verapamil hydrochloride) extendedrelease oral tablet, 180 mg, may 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: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2016–26932 Filed 11–7–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3631]
Ninth Annual Sentinel Initiative; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Ninth
Annual Sentinel Initiative Public
Workshop.’’ Convened by the DukeMargolis Center for Health Policy at
Duke University and supported by a
cooperative agreement with FDA, this 1day workshop will bring the stakeholder
community together to discuss a variety
of topics on active medical product
surveillance. Topics will include an
update on the state of FDA’s Sentinel
Initiative, including an overview of the
current state of Sentinel System safety
surveillance activities, and uses of the
Sentinel System accomplished in 2016.
In addition, panelists will discuss the
future of the Sentinel System and
opportunities to expand its medical
product surveillance capabilities. This
workshop will also engage stakeholders
to discuss current and emerging
Sentinel Initiative projects.
DATES: The public workshop will be
held on February 2, 2017, from 9 a.m.
to 4:30 p.m., Eastern Standard Time
(EST). Submit either electronic or
written comments by March 2, 2017.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:27 Nov 07, 2016
Jkt 241001
Location: The public
workshop will be held at the Barbara
Jordan Conference Center at the Kaiser
Family Foundation, 1330 G St. NW.,
Washington, DC 20005. For additional
travel and hotel information, please
refer to https://healthpolicy.duke.edu/
events/ninth-annual-sentinel-initiativepublic-workshop. FDA has verified the
meeting Web site addresses throughout
this notice, but FDA is not responsible
for subsequent changes to the Web sites
after this document publishes in the
Federal Register. There will also be a
live Webcast for those unable to attend
the meeting in person (see Streaming
Webcast of the Public Workshop).
You may submit comments as
follows:
ADDRESSES:
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
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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.’’
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
78607
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–3631 for ‘‘Ninth Annual
Sentinel Initiative; Public Workshop.’’
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
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Carlos Bell, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4343, Silver Spring,
MD 20993–0002, 301–796–3714, FAX:
301–796–9832, email:
SentinelInitiative@fda.hhs.gov.
E:\FR\FM\08NON1.SGM
08NON1
]]>Agencies
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78606-78607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26932]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-2674]
Determination That CALAN SR (Verapamil Hydrochloride) Extended-
Release Oral Tablet, 180 Milligrams, Was 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 CALAN SR (verapamil hydrochloride) extended-release
oral tablet, 180 milligrams (mg), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for verapamil
hydrochloride extended-release oral tablet, 180 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.
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.
CALAN SR (verapamil hydrochloride) extended-release oral tablet,
180 mg, is the subject of NDA 019152 held by Pfizer Inc. CALAN SR is
indicated for the treatment of hypertension, to lower blood pressure.
CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180
mg, is currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Heritage Pharma Labs, Inc., submitted a citizen petition dated
August 31, 2016 (Docket No. FDA-2016-P-2674), under 21 CFR 10.30,
requesting that the Agency determine whether CALAN SR (verapamil
hydrochloride) extended-release oral tablet, 180 mg, was withdrawn from
sale for reasons of safety or effectiveness.
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 CALAN SR (verapamil hydrochloride)
extended-release oral tablet, 180 mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that CALAN SR (verapamil hydrochloride)
extended-release oral tablet, 180 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of CALAN SR (verapamil hydrochloride)
extended-release oral tablet, 180 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list CALAN SR (verapamil
hydrochloride) extended-release oral
[[Page 78607]]
tablet, 180 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. ANDAs that
refer to CALAN SR (verapamil hydrochloride) extended-release oral
tablet, 180 mg, may 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: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26932 Filed 11-7-16; 8:45 am]
BILLING CODE 4164-01-P
