Determination That FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 12613-12614 [2017-04231]
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Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(b) How do you/your child weigh the
potential benefits of these treatments
versus the common side effects of the
treatments? (Common side effects could
include headache, nausea, fatigue,
weight gain)
(c) How do you/your child weigh
potential benefits of these treatments
versus the less common but serious
risks associated with the treatments?
(Examples of less common but serious
risks are infections, organ damage or
failure, suicidal thoughts)
Dated February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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Determination That FLONASE
(Fluticasone Propionate) Nasal Spray,
0.05 Milligram, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
[FR Doc. 2017–04229 Filed 3–3–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–1725]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that prescription FLONASE
(fluticasone propionate) Nasal Spray,
0.05 milligram (mg), was not withdrawn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 this
determination will allow FDA to
continue to approve ANDAs for
fluticasone propionate nasal spray, 0.05
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
David Faranda, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 301–
796–8767.
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.
SUMMARY:
PO 00000
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Fmt 4703
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12613
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.
Prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, is the
subject of NDA 020121, held by
GlaxoSmithKline, and initially
approved on October 19, 1994.
FLONASE is indicated for the
management of the nasal symptoms of
perennial nonallergic rhinitis in adult
and pediatric patients aged 4 years and
older.
In a letter dated May 25, 2016,
GlaxoSmithKline notified FDA that
prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated June
20, 2016 (Docket No. FDA–2016–P–
1725), under 21 CFR 10.30, requesting
that the Agency determine whether
prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 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 prescription FLONASE
(fluticasone propionate) Nasal Spray,
0.05 mg, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that this drug
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, from
E:\FR\FM\06MRN1.SGM
06MRN1
12614
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
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 prescription FLONASE
(fluticasone propionate) Nasal Spray,
0.05 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 prescription
FLONASE (fluticasone propionate)
Nasal Spray, 0.05 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: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04231 Filed 3–3–17; 8:45 am]
BILLING CODE 4164–01–P
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4842, FAX: 301–796–9858,
email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of a rare
pediatric disease product application.
Under section 529 of the FD&C Act (21
U.S.C. 360ff), which was added by
FDASIA, FDA will award priority
review vouchers to sponsors of rare
pediatric disease product applications
that meet certain criteria. FDA has
determined that SPINRAZA
(nusinersen), manufactured by Biogen
Inc., meets the criteria for a priority
review voucher. SPINRAZA
(nusinersen) is indicated for the
treatment of spinal muscular atrophy in
pediatric and adult patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about SPINRAZA
(nusinersen), go to the ‘‘Drugs@FDA’’
Web site at https://www.accessdata.fda.
gov/scripts/cder/daf/.
Dated: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–04228 Filed 3–3–17; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
rare pediatric disease product
applications that meet certain criteria.
FDA has determined that SPINRAZA
(nusinersen), manufactured by Biogen
Inc., meets the criteria for a priority
review voucher.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and
Research, Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
19:24 Mar 03, 2017
Meeting of the 2018 Physical Activity
Guidelines Advisory Committee
U.S. Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office of Disease Prevention and
Health Promotion.
ACTION: Notice.
AGENCY:
SUMMARY:
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 241001
As stipulated by the Federal
Advisory Committee Act (FACA), the
U.S. Department of Health and Human
Services (HHS) is hereby giving notice
that the third meeting of the 2018
Physical Activity Guidelines Advisory
Committee (2018 PAGAC or Committee)
will be held. This meeting will be open
to the public via videocast.
DATES: The meeting will be held on
March 23, 2017, from 8:00 a.m. E.T. to
5:30 p.m. E.T.
ADDRESSES: The meeting will be
accessible by videocast on the Internet.
SUMMARY:
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Designated Federal Officer, 2018
Physical Activity Guidelines Advisory
Committee, Richard D. Olson, M.D.,
M.P.H. and/or Alternate Designated
Federal Officer, Katrina L. Piercy, Ph.D.,
R.D., Office of Disease Prevention and
Health Promotion (ODPHP), Office of
the Assistant Secretary for Health
(OASH), HHS; 1101 Wootton Parkway,
Suite LL–100; Rockville, MD 20852;
Telephone: (240) 453–8280. Additional
information is available at
www.health.gov/paguidelines.
SUPPLEMENTARY INFORMATION: The
inaugural Physical Activity Guidelines
for Americans (PAG), issued in 2008,
represents the first comprehensive
guidelines on physical activity issued
by the federal government. The PAG
serves as the benchmark and primary,
authoritative voice of the federal
government for providing science-based
guidance on physical activity, fitness,
and health for Americans. Five years
after the first edition was released,
ODPHP, in collaboration with the
Centers for Disease Control and
Prevention (CDC), the National
Institutes of Health (NIH), and the
President’s Council on Fitness, Sports,
and Nutrition (PCFSN) led development
of the PAG Midcourse Report: Strategies
to Increase Physical Activity Among
Youth. The second edition of the PAG
will build upon the first edition and
provide a foundation for federal
recommendations and education for
physical activity programs for
Americans, including those at risk for
chronic disease.
Appointed Committee Members: The
Secretary of HHS appointed 17
individuals to serve as members of the
2018 PAGAC in June 2016. Information
on Committee membership is available
at www.health.gov/paguidelines/secondedition/committee/.
Committee’s Task: The work of the
2018 PAGAC will be time-limited and
solely advisory in nature. The
Committee will develop
recommendations based on the
preponderance of current scientific and
medical knowledge using a systematic
review approach. The Committee will
examine the current PAG, take into
consideration new scientific evidence
and current resource documents, and
develop a scientific report to the
Secretary of HHS that outlines its
science-based advice and
recommendations for development of
the second edition of the PAG. The
Committee will hold approximately five
public meetings to review and discuss
recommendations. The first meeting was
held in July 2016 and the second in
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12613-12614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04231]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-1725]
Determination That FLONASE (Fluticasone Propionate) Nasal Spray,
0.05 Milligram, 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 prescription FLONASE (fluticasone propionate) Nasal
Spray, 0.05 milligram (mg), was 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 this
determination will allow FDA to continue to approve ANDAs for
fluticasone propionate nasal spray, 0.05 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-8767.
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.
Prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 mg,
is the subject of NDA 020121, held by GlaxoSmithKline, and initially
approved on October 19, 1994. FLONASE is indicated for the management
of the nasal symptoms of perennial nonallergic rhinitis in adult and
pediatric patients aged 4 years and older.
In a letter dated May 25, 2016, GlaxoSmithKline notified FDA that
prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 mg, was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated June 20, 2016 (Docket No. FDA-2016-P-1725), under 21 CFR 10.30,
requesting that the Agency determine whether prescription FLONASE
(fluticasone propionate) Nasal Spray, 0.05 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 prescription FLONASE (fluticasone propionate)
Nasal Spray, 0.05 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, from
[[Page 12614]]
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 prescription FLONASE
(fluticasone propionate) Nasal Spray, 0.05 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 prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 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: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04231 Filed 3-3-17; 8:45 am]
BILLING CODE 4164-01-P
