Determination That SYMMETREL (Amantadine Hydrochloride), Syrup, 50 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 5580-5581 [2017-01064]
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5580
Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
abbreviated licensure pathway in
section 351(k) for biological products
shown to be biosimilar to or
interchangeable with an FDA-licensed
biological reference product (see
sections 7001 through 7003 of the
Patient Protection and Affordable Care
Act Of 2010 (Affordable Care Act) (Pub.
L. 111–148)).
Section 351(k) of the PHS Act sets
forth the requirements for an
application for a proposed biosimilar
product and an application or a
supplement for a proposed
interchangeable product. Specifically,
section 351(k)(4) provides that upon
review of an application submitted
under section 351(k), or any supplement
to such an application, FDA will
determine the biological product to be
interchangeable with the reference
product if FDA determines that the
information submitted in the
application (or supplement) is sufficient
to show that the biological product is
biosimilar to the reference product and
can be expected to produce the same
clinical result as the reference product
in any given patient; and for a biological
product that is administered more than
once to an individual, the risk in terms
of safety or diminished efficacy of
alternating or switching between use of
the biological product and the reference
product is not greater than the risk of
using the reference product without
such alternation or switch. Section
351(i) of the PHS Act states that the
term interchangeable or
interchangeability, in reference to a
biological product that is shown to meet
the standards described in subsection
351(k)(4), means that the biological
product may be substituted for the
reference product without the
intervention of the health care provider
who prescribed the reference product.
This guidance gives an overview of
important scientific considerations in
demonstrating interchangeability,
including:
• The data and information needed to
support a demonstration of
interchangeability;
• Considerations for the design and
analysis of a switching study or studies
to support a demonstration of
interchangeability;
• Recommendations regarding the use
of U.S.-licensed reference products in a
switching study or studies; and
• Considerations for developing
presentations, container closure
systems, and delivery device constituent
parts for proposed interchangeable
products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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The draft guidance, when finalized, will
represent the current thinking of FDA
on topics sponsors should consider
when seeking to demonstrate that a
proposed therapeutic protein product is
interchangeable with a reference
product. It does not establish any rights
for any person and is not binding on
FDA or the public.
II. Topics for Comment
In addition to comment on the draft
guidance, we also invite general
comments on interchangeability,
including comments on regulation of an
interchangeable product over its
lifecycle, as well as comments on the
following topics:
1. Since the mid-1990s, FDA has
approved manufacturing changes for
biological products based on data from
comparability assessments comparing
the pre-change and post-change product
using comparative analytical, and, when
necessary, animal and/or clinical (e.g.,
pharmacokinetic, immunogenicity)
studies. A demonstration of
comparability between pre- and postchange product supports a
determination that the safety and
efficacy profile remains the same for the
product. With respect to
interchangeable products, are there
considerations in addition to
comparability assessments that FDA
should consider in regulating postapproval manufacturing changes of
interchangeable products? Your
comments should include the scientific
rationale and justification for your
recommendations, as well as
recommendations for processes and
systems (including key logistics) to
implement your recommendations.
2. As explained in the guidance
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product,’’ FDA expects that sponsors
seeking an interchangeability
determination will submit data and
information to support a showing that
the proposed interchangeable product
can be expected to produce the same
clinical result as the reference product
in all of the reference product’s licensed
conditions of use. How, if at all, should
the Agency consider conditions of use
that are licensed for the reference
product after an interchangeable
product has been licensed? Your
comments should include the scientific
rationale and justification for your
recommendations, as well as
recommendations for processes and
systems (including key logistics) to
implement your recommendations.
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III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information under 21 CFR part 312
have been approved under OMB control
number 0910–0014; the collections of
information under 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information under section 351(k) of
the PHS Act have been approved under
OMB control number 0910–0719.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft 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.
Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–01042 Filed 1–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–2469]
Determination That SYMMETREL
(Amantadine Hydrochloride), Syrup, 50
Milligrams/5 Milliliters, 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 SYMMETREL
(amantadine hydrochloride), Syrup, 50
milligrams/5 milliliters (50 mg/5 mL),
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 SYMMETREL,
and it will allow FDA to continue to
approve ANDAs that reference
SYMMETREL if all other legal and
regulatory requirements are met.
SUMMARY:
E:\FR\FM\18JAN1.SGM
18JAN1
Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Stefanie S. Kraus, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215,
Silver Spring, MD 20993–0002, 301–
796–9585.
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, is
the subject of NDAs 016023 and 017118,
held by Endo Pharmaceuticals, and
initially approved on February 14, 1968,
and July 20, 1976, respectively.
SYMMETREL is indicated for the
prophylaxis and treatment of signs and
symptoms of infection caused by
various strains of influenza A virus.
SYMMETREL is also indicated for the
treatment of parkinsonism and druginduced extrapyramidal reactions.
VerDate Sep<11>2014
17:41 Jan 17, 2017
Jkt 241001
In a letter dated March 19, 2009, Endo
Pharmaceuticals notified FDA that
SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, was
being discontinued and requested
withdrawal of NDA016023 for that
product. FDA moved the drug product
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book and
announced in the Federal Register of
July 21, 2010 (75 FR 42455), that FDA
was withdrawing approval of NDA
016023, effective August 20, 2010.
Hyman, Phelps & McNamara
submitted a citizen petition dated
August 3, 2016 (Docket No. FDA–2016–
P–2469), under 21 CFR 10.30,
requesting that the Agency determine
whether SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, 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 SYMMETREL
(amantadine hydrochloride), Syrup, 50
mg/5 mL, 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
SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL,
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 not withdrawn from sale
for reasons of safety or effectiveness.1
Accordingly, the Agency will
continue to list SYMMETREL
(amantadine hydrochloride), Syrup, 50
mg/5 mL, 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
1 Due to high levels of resistance to currently
circulating Influenza A viruses, the Centers for
Disease Control and Prevention currently
recommends against using amantadine to treat
Influenza A. Given the potential for viral
reassortment, however, amantadine may be
effective against future Influenza A viruses.
Consistent with this, the current label for
SYMMETREL (amantadine hydrochloride), Syrup,
50 mg/5 mL, was revised to caution prescribers to
consider susceptibility and clinical benefit when
deciding whether to use amantadine to treat
Influenza A.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
5581
to SYMMETREL. Additional ANDAs
that refer to SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL,
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: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–01064 Filed 1–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0026]
Assessment of Abuse Potential of
Drugs; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Assessment of Abuse Potential of
Drugs.’’ This guidance is intended to
assist sponsors of investigational new
drugs and applicants for approval of a
new drug in evaluating whether their
new drug product has abuse potential.
Specifically, this guidance provides
recommendations for assessing the
abuse potential of central nervous
system (CNS)-active new drugs. Drug
products with abuse potential generally
contain drug substances that are active
within the CNS and produce
psychoactive effects such as euphoria
and hallucinations. Thus, if a drug
substance is CNS-active, the new drug
product containing that drug substance
will likely need to undergo a thorough
assessment of its abuse potential and
may be subject to control under the
Controlled Substances Act (CSA). This
guidance finalizes the draft guidance of
the same name issued on January 27,
2010.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5580-5581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-2469]
Determination That SYMMETREL (Amantadine Hydrochloride), Syrup,
50 Milligrams/5 Milliliters, 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 SYMMETREL (amantadine hydrochloride), Syrup, 50
milligrams/5 milliliters (50 mg/5 mL), 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 SYMMETREL, and it will allow FDA to
continue to approve ANDAs that reference SYMMETREL if all other legal
and regulatory requirements are met.
[[Page 5581]]
FOR FURTHER INFORMATION CONTACT: Stefanie S. Kraus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-9585.
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.
SYMMETREL (amantadine hydrochloride), Syrup, 50 mg/5 mL, is the
subject of NDAs 016023 and 017118, held by Endo Pharmaceuticals, and
initially approved on February 14, 1968, and July 20, 1976,
respectively. SYMMETREL is indicated for the prophylaxis and treatment
of signs and symptoms of infection caused by various strains of
influenza A virus. SYMMETREL is also indicated for the treatment of
parkinsonism and drug-induced extrapyramidal reactions.
In a letter dated March 19, 2009, Endo Pharmaceuticals notified FDA
that SYMMETREL (amantadine hydrochloride), Syrup, 50 mg/5 mL, was being
discontinued and requested withdrawal of NDA016023 for that product.
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book and announced in the Federal Register of
July 21, 2010 (75 FR 42455), that FDA was withdrawing approval of NDA
016023, effective August 20, 2010.
Hyman, Phelps & McNamara submitted a citizen petition dated August
3, 2016 (Docket No. FDA-2016-P-2469), under 21 CFR 10.30, requesting
that the Agency determine whether SYMMETREL (amantadine hydrochloride),
Syrup, 50 mg/5 mL, 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 SYMMETREL (amantadine hydrochloride), Syrup,
50 mg/5 mL, 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 SYMMETREL (amantadine hydrochloride),
Syrup, 50 mg/5 mL, 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 not withdrawn from sale for reasons of safety or
effectiveness.\1\
---------------------------------------------------------------------------
\1\ Due to high levels of resistance to currently circulating
Influenza A viruses, the Centers for Disease Control and Prevention
currently recommends against using amantadine to treat Influenza A.
Given the potential for viral reassortment, however, amantadine may
be effective against future Influenza A viruses. Consistent with
this, the current label for SYMMETREL (amantadine hydrochloride),
Syrup, 50 mg/5 mL, was revised to caution prescribers to consider
susceptibility and clinical benefit when deciding whether to use
amantadine to treat Influenza A.
---------------------------------------------------------------------------
Accordingly, the Agency will continue to list SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, 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 SYMMETREL. Additional ANDAs that refer to
SYMMETREL (amantadine hydrochloride), Syrup, 50 mg/5 mL, 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: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01064 Filed 1-17-17; 8:45 am]
BILLING CODE 4164-01-P
