Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 71044 [2011-29484]
Download as PDF
<![CDATA[
71044
Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0416]
Determination That TRAVATAN
(Travoprost Ophthalmic Solution),
0.004%, Was Not Withdrawn From Sale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) has determined
that TRAVATAN (travoprost
ophthalmic solution), 0.004%, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for travoprost
ophthalmic solution, 0.004%, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Olivia J.E. Morris, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6260,
Silver Spring, MD 20993–0002, (301)
796–3601.
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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:45 Nov 15, 2011
Jkt 226001
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.
TRAVATAN (travoprost ophthalmic
solution), 0.004%, is the subject of NDA
21–257, held by Alcon Pharmaceuticals,
Ltd., and initially approved on March
16, 2001. TRAVATAN is indicated for
the reduction of elevated intraocular
pressure in patients with open angle
glaucoma or ocular hypertension.
TRAVATAN (travoprost ophthalmic
solution), 0.004%, is currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.
submitted a citizen petition dated May
25, 2011 (Docket No. FDA–2011–P–
0416), under 21 CFR 10.30, requesting
that the Agency determine whether
TRAVATAN (travoprost ophthalmic
solution), 0.004%, was voluntarily
withdrawn or withheld 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 TRAVATAN (travoprost
ophthalmic solution), 0.004%, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that TRAVATAN (travoprost
ophthalmic solution), 0.004%, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
TRAVATAN (travoprost ophthalmic
solution), 0.004%, 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 product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list TRAVATAN (travoprost
ophthalmic solution), 0.004%, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to TRAVATAN (travoprost ophthalmic
solution), 0.004%, 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 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29484 Filed 11–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0720]
International Conference on
Harmonisation; E2B(R3) Electronic
Transmission of Individual Case Safety
Reports; Draft Guidance on
Implementation; Data Elements and
Message Specification; Appendix on
Backwards and Forwards
Compatibility; Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Thursday, October 20, 2011
(76 FR 65199). The document
announced the availability of a draft
guidance entitled ‘‘E2B(R3) Electronic
Transmission of Individual Case Safety
Reports (ICSRs): Implementation
Guide—Data Elements and Message
Specification’’ (the draft E2B(R3)
implementation guidance) and an
appendix to the draft guidance entitled
‘‘ICSRs: Appendix to the
Implementation Guide—Backwards and
Forwards Compatibility’’ (the draft BFC
appendix). The document was
published with an incorrect date in the
DATES section. This document corrects
that error.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993–0002, (301)
796–3601.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–27147, appearing on page 65199
SUMMARY:
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Page 71044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29484]
[[Page 71044]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0416]
Determination That TRAVATAN (Travoprost Ophthalmic Solution),
0.004%, 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) has determined that
TRAVATAN (travoprost ophthalmic solution), 0.004%, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
travoprost ophthalmic solution, 0.004%, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Olivia J.E. Morris, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6260, Silver Spring, MD 20993-0002, (301)
796-3601.
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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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.
TRAVATAN (travoprost ophthalmic solution), 0.004%, is the subject
of NDA 21-257, held by Alcon Pharmaceuticals, Ltd., and initially
approved on March 16, 2001. TRAVATAN is indicated for the reduction of
elevated intraocular pressure in patients with open angle glaucoma or
ocular hypertension.
TRAVATAN (travoprost ophthalmic solution), 0.004%, is currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Lachman Consultant Services, Inc. submitted a citizen petition
dated May 25, 2011 (Docket No. FDA-2011-P-0416), under 21 CFR 10.30,
requesting that the Agency determine whether TRAVATAN (travoprost
ophthalmic solution), 0.004%, was voluntarily withdrawn or withheld
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 TRAVATAN (travoprost ophthalmic
solution), 0.004%, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that TRAVATAN (travoprost ophthalmic solution),
0.004%, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
TRAVATAN (travoprost ophthalmic solution), 0.004%, 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 product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list TRAVATAN (travoprost
ophthalmic solution), 0.004%, 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 TRAVATAN (travoprost ophthalmic
solution), 0.004%, 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 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29484 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P
