Office of the Director; Notice of Charter Renewal, 13670 [2019-06615]
Download as PDF
<![CDATA[
khammond on DSKBBV9HB2PROD with NOTICES
13670
Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Notices
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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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time after the drug has been withdrawn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.
ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets,
12.5 mg, 25 mg, and 50 mg, are the
subject of NDA 010721, currently held
by Casper Pharma LLC, and initially
approved on February 14, 1957.
ANTIVERT is indicated for the
treatment of vertigo associated with
diseases affecting the vestibular system.
ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets,
12.5 mg, 25 mg, and 50 mg, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Since 2011, the Agency has received
four citizen petitions, submitted under
21 CFR 10.30, requesting that FDA
determine whether one or more dosage
forms and strengths of ANTIVERT were
withdrawn from sale for reasons of
safety or effectiveness.
• InvaGen Pharmaceuticals submitted
a citizen petition dated January 14,
2011, and amendment dated February
24, 2011 (Docket No. FDA–2011–P–
VerDate Sep<11>2014
18:46 Apr 04, 2019
Jkt 247001
0047), requesting that the Agency
determine whether ANTIVERT
(meclizine hydrochloride) chewable
tablets, 25 mg, was withdrawn from sale
for reasons of safety or effectiveness.
• Modavar Pharmaceuticals LLC
submitted a citizen petition dated May
4, 2012, (Docket No. FDA–2012–P–
0468) requesting that the Agency
determine whether ANTIVERT
(meclizine hydrochloride) tablets, 12.5
mg and 25 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
• Lupin Pharmaceuticals, Inc.
submitted a citizen petition dated
September 18, 2015 (Docket No. FDA–
2015–P–3400), requesting that the
Agency determine whether ANTIVERT
(meclizine hydrochloride) tablets, 12.5
mg, 25 mg, and 50 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
• Zydus Pharmaceuticals submitted a
citizen petition dated June 14, 2016
(Docket No. FDA–2016–P–1667),
requesting that the Agency determine
whether ANTIVERT (meclizine
hydrochloride) tablets, 12.5 mg and 25
mg, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records, and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ANTIVERT (meclizine
hydrochloride) chewable tablets, 25 mg,
and tablets, 12.5 mg, 25 mg, and 50 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioners
have 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
ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets,
12.5 mg, 25 mg, and 50 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
post marketing adverse events. We have
found no information that would
indicate that these drug products were
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list ANTIVERT
(meclizine hydrochloride) chewable
tablets, 25 mg, and tablets, 12.5 mg, 25
mg, and 50 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–06656 Filed 4–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Center for
Scientific Review Advisory Council
(CSRAC) was renewed for an additional
two-year period on March 31, 2019.
It is determined that the CSRAC is in
the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquiries may be directed to Claire
Harris, Acting Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Code 4875), Telephone (301) 496–
2123, or harriscl@mail.nih.gov.
Dated: April 1, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–06615 Filed 4–4–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request: A Generic Submission for
Formative Research, Pretesting and
Customer Satisfaction of NCI’s
Communication and Education
Resources (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
E:\FR\FM\05APN1.SGM
Notice.
05APN1
]]>Agencies
[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Notices]
[Page 13670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06615]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter Renewal
In accordance with Title 41 of the U.S. Code of Federal
Regulations, Section 102-3.65(a), notice is hereby given that the
Charter for the Center for Scientific Review Advisory Council (CSRAC)
was renewed for an additional two-year period on March 31, 2019.
It is determined that the CSRAC is in the public interest in
connection with the performance of duties imposed on the National
Institutes of Health by law, and that these duties can best be
performed through the advice and counsel of this group.
Inquiries may be directed to Claire Harris, Acting Director, Office
of Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail Code 4875), Telephone (301) 496-2123, or
[email protected].
Dated: April 1, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-06615 Filed 4-4-19; 8:45 am]
BILLING CODE 4140-01-P
