Determination That SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27320-27321 [2015-11529]
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Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on nonclinical assessment of
investigational ERT products. 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.
Dated: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
II. The Paperwork Reduction Act of
1995
[Docket No. FDA–2015–N–1339]
This guidance refers to previously
approved collections of information that
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 in 21 CFR part 312 have
been approved under OMB control
number 0910–0014, and the information
collection in the regulations on good
laboratory practice for nonclinical
laboratory studies (21 CFR part 58) is
approved under OMB control number
0910–0119.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
[FR Doc. 2015–11539 Filed 5–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Determination That SODIUM SULAMYD
(sulfacetamide sodium) Ophthalmic
Solution and Ophthalmic Ointment
Were Not Withdrawn From Sale for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 the drug products listed
in this document 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
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Amy Hopkins, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223,
Silver Spring, MD 20993–0002, 301–
796–5418, Amy.Hopkins@fda.hhs.gov.
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 approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
SUMMARY:
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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is 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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
(As requested by the applicant, FDA
withdrew approval of NDA 005963 for
SODIUM SULAMYD (sulfacetamide
sodium) Ophthalmic Solution and
Ophthalmic Ointment in the Federal
Register of August 16, 2001 (66 FR
43017)).
Drug
Applicant
NDA 005963 ........................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Application No.
SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution 10%, Ophthalmic Solution 30%, and
Ophthalmic Ointment 10%.
Schering Plough Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
VerDate Sep<11>2014
17:27 May 12, 2015
Jkt 235001
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
E:\FR\FM\13MYN1.SGM
13MYN1
Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
Approved ANDAs that refer to the
NDA listed in this document are
unaffected by the discontinued
marketing of the products subject to this
NDA. Additional ANDAs that refer to
these products may also be approved by
the Agency if they comply with relevant
legal and regulatory requirements. 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: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Dated: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Biosimilars: Additional Questions and
Answers Regarding Implementation of
the Biologics Price Competition and
Innovation Act of 2009; Draft Guidance
for Industry; Availability
[FR Doc. 2015–11529 Filed 5–12–15; 8:45 am]
BILLING CODE 4164–01–P
[FR Doc. 2015–11526 Filed 5–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0611]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
[Docket No. FDA–2008–N–0312]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Extra Label Drug Use in Animals
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Extra Label Drug Use in Animals’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On
February 18, 2015, the Agency
submitted a proposed collection of
information entitled, ‘‘Extra Label Drug
Use in Animals’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0325. The
approval expires on March 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:27 May 12, 2015
Jkt 235001
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Biosimilars: Additional Questions and
Answers Regarding Implementation of
the Biologics Price Competition and
Innovation Act of 2009.’’ This draft
guidance is intended to provide answers
to common questions from sponsors
interested in developing proposed
biosimilar products, biologics license
application (BLA) holders, and other
interested parties regarding FDA’s
interpretation of the Biologics Price
Competition and Innovation Act of 2009
(BPCI Act). This guidance revises the
draft guidance entitled ‘‘Biosimilars:
Questions and Answers Regarding
Implementation of the Biologics Price
Competition and Innovation Act of
2009,’’ issued February 15, 2012, to
provide new and revised questions and
answers (Q&As).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 13, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
Outreach and Development (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 3128, Silver Spring,
SUMMARY:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
27321
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993–0002, 301–
796–1042, 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 revised draft guidance for industry
entitled ‘‘Biosimilars: Additional
Questions and Answers Regarding
Implementation of the Biologics Price
Competition and Innovation Act of
2009.’’ This draft guidance provides
answers to common questions from
sponsors interested in developing
proposed biosimilar products, BLA
holders, and other interested parties
regarding FDA’s interpretation of the
BPCI Act. This guidance revises the
draft guidance entitled ‘‘Biosimilars:
Questions and Answers Regarding
Implementation of the Biologics Price
Competition and Innovation Act of
2009,’’ issued February 15, 2012, to
provide new and revised Q&As. It also
includes certain original Q&As that have
not yet been finalized.
The BPCI Act, enacted as part of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148) on March 23,
2010, created an abbreviated licensure
pathway under section 351(k) of the
Public Health Service Act (the PHS Act)
(42 U.S.C. 262(k)) for biological
products demonstrated to be biosimilar
to, or interchangeable with, an FDAlicensed reference product. This draft
guidance describes FDA’s current
interpretation of certain statutory
requirements added by the BPCI Act
and includes Q&As in the following
categories:
• Biosimilarity or Interchangeability
• Provisions Related to Requirement
to Submit a BLA for a ‘‘Biological
Product’’
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27320-27321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11529]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1339]
Determination That SODIUM SULAMYD (sulfacetamide sodium)
Ophthalmic Solution and Ophthalmic Ointment 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 the drug products listed in this document 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
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Amy Hopkins, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, Amy.Hopkins@fda.hhs.gov.
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 approved 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 generally known as the ``Orange
Book.'' Under FDA regulations, a drug is 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicant, FDA withdrew approval of NDA 005963 for SODIUM SULAMYD
(sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment in
the Federal Register of August 16, 2001 (66 FR 43017)).
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 005963.................. SODIUM SULAMYD Schering Plough
(sulfacetamide Corp., 2000
sodium) Ophthalmic Galloping Hill Rd.,
Solution 10%, Kenilworth, NJ
Ophthalmic Solution 07033.
30%, and Ophthalmic
Ointment 10%.
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
[[Page 27321]]
Approved ANDAs that refer to the NDA listed in this document are
unaffected by the discontinued marketing of the products subject to
this NDA. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. 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: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11529 Filed 5-12-15; 8:45 am]
BILLING CODE 4164-01-P
