81 FR 4310 - Determination That IZBA (Travoprost Ophthalmic Solution), 0.003 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 16 (January 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 16 (January 26, 2016)
| Page Range | 4310-4311 | |
| FR Document | 2016-01473 |
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)] [Notices] [Pages 4310-4311] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01473] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-P-3053] Determination That IZBA (Travoprost Ophthalmic Solution), 0.003 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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Drug Administration (FDA or Agency) has determined that IZBA (travoprost ophthalmic solution), 0.003 percent, was not withdrawn from sale for reasons of safety or effectiveness.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/drops, 0.003 percent, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240- 402-1748. 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 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. IZBA (travoprost ophthalmic solution), 0.003 percent, is the subject of NDA 204822, held by Alcon Laboratories, Inc., and initially approved on May 15, 2014. IZBA is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In a letter dated September 4, 2015, Alcon Laboratories, Inc. notified FDA that IZBA (travoprost ophthalmic solution), 0.003 percent, was discontinued. IZBA (travoprost ophthalmic solution), 0.003 percent, is currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Jonathan Goodman of Florek & Endres PLLC submitted a citizen petition dated August 20, 2015 (Docket No. FDA-2015-P-3053), under 21 CFR 10.30, requesting that the Agency determine whether IZBA (travoprost ophthalmic solution), 0.003 percent, 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 IZBA (travoprost ophthalmic solution), 0.003 percent, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that IZBA (travoprost ophthalmic solution), 0.003 percent, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of IZBA (travoprost ophthalmic solution), 0.003 percent, 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 IZBA (travoprost ophthalmic solution), 0.003 percent, 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 IZBA (travoprost ophthalmic solution), 0.003 percent, 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. [[Page 4311]] Dated: January 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01473 Filed 1-25-16; 8:45 am] BILLING CODE 4164-01-P
![4310 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices
ECDD at its 37th meeting recommended ACTION: Notice. NDA 204822, held by Alcon
that MXE be placed in Schedule II of the Laboratories, Inc., and initially
Psychotropic Convention. MXE is not SUMMARY: The Food and Drug approved on May 15, 2014. IZBA is
currently controlled under the CSA in Administration (FDA or Agency) has indicated for the reduction of elevated
the United States. Additional controls determined that IZBA (travoprost intraocular pressure in patients with
will be necessary to fulfill U.S. ophthalmic solution), 0.003 percent, open-angle glaucoma or ocular
obligations if MXE is controlled under was not withdrawn from sale for reasons hypertension.
Schedule II of the Psychotropic of safety or effectiveness. This In a letter dated September 4, 2015,
Convention. determination will allow FDA to Alcon Laboratories, Inc. notified FDA
FDA, on behalf of the Secretary of approve abbreviated new drug that IZBA (travoprost ophthalmic
HHS, invites interested persons to applications (ANDAs) for travoprost solution), 0.003 percent, was
submit comments on the notifications ophthalmic solution/drops, 0.003 discontinued. IZBA (travoprost
from the United Nations concerning percent, if all other legal and regulatory ophthalmic solution), 0.003 percent, is
these drug substances. FDA, in requirements are met. currently listed in the ‘‘Discontinued
cooperation with the National Institute FOR FURTHER INFORMATION CONTACT: Kate Drug Product List’’ section of the Orange
on Drug Abuse, will consider the Greenwood, Center for Drug Evaluation Book.
comments on behalf of HHS in and Research, Food and Drug Jonathan Goodman of Florek & Endres
evaluating the WHO scheduling Administration, 10903 New Hampshire PLLC submitted a citizen petition dated
recommendations. Then, under section Ave., Bldg. 51, Rm. 6286, Silver Spring, August 20, 2015 (Docket No. FDA–
201(d)(2)(B) of the CSA, HHS will MD 20993–0002, 240–402–1748. 2015–P–3053), under 21 CFR 10.30,
recommend to the Secretary of State SUPPLEMENTARY INFORMATION: In 1984, requesting that the Agency determine
what position the United States should Congress enacted the Drug Price whether IZBA (travoprost ophthalmic
take when voting on the Competition and Patent Term solution), 0.003 percent, was withdrawn
recommendations for control of Restoration Act of 1984 (Pub. L. 98–417) from sale for reasons of safety or
substances under the Psychotropic (the 1984 amendments), which effectiveness.
Convention at the CND meeting in authorized the approval of duplicate After considering the citizen petition
March 2015. versions of drug products under an and reviewing Agency records and
Comments regarding the WHO ANDA procedure. ANDA applicants based on the information we have at this
recommendations for control of must, with certain exceptions, show that time, FDA has determined under
acetylfentanyl and MT-45 under the the drug for which they are seeking § 314.161 that IZBA (travoprost
1961 Single Convention will also be approval contains the same active ophthalmic solution), 0.003 percent,
forwarded to the relevant Agencies for ingredient in the same strength and was not withdrawn for reasons of safety
consideration in developing the U.S. dosage form as the ‘‘listed drug,’’ which or effectiveness. The petitioner has
position regarding narcotic substances is a version of the drug that was identified no data or other information
at the CND meeting. previously approved. ANDA applicants suggesting that IZBA (travoprost
do not have to repeat the clinical testing ophthalmic solution), 0.003 percent,
IV. Opportunity for Public Meeting was withdrawn for reasons of safety or
otherwise necessary to gain approval of
FDA does not presently plan to hold a new drug application (NDA). effectiveness. We have carefully
a public meeting. If any person believes The 1984 amendments include what reviewed our files for records
that, in addition to written comments, a is now section 505(j)(7) of the Federal concerning the withdrawal of IZBA
public meeting would contribute to the Food, Drug, and Cosmetic Act (21 U.S.C. (travoprost ophthalmic solution), 0.003
development of the U.S. position on the 355(j)(7)), which requires FDA to percent, from sale. We have also
substances to be considered for control publish a list of all approved drugs. independently evaluated relevant
under the Psychotropic Convention, a FDA publishes this list as part of the literature and data for possible
request for a public meeting and the ‘‘Approved Drug Products With postmarketing adverse events. We have
reasons for such a request should be Therapeutic Equivalence Evaluations,’’ found no information that would
sent to James R. Hunter (see FOR which is known generally as the indicate that this product was
FURTHER INFORMATION CONTACT) on or ‘‘Orange Book.’’ Under FDA regulations, withdrawn from sale for reasons of
before February 5, 2016. drugs are removed from the list if the safety or effectiveness.
Dated: January 20, 2016. Agency withdraws or suspends Accordingly, the Agency will
Leslie Kux, approval of the drug’s NDA or ANDA continue to list IZBA (travoprost
for reasons of safety or effectiveness or ophthalmic solution), 0.003 percent, in
Associate Commissioner for Policy.
if FDA determines that the listed drug the ‘‘Discontinued Drug Product List’’
[FR Doc. 2016–01474 Filed 1–25–16; 8:45 am]
was withdrawn from sale for reasons of section of the Orange Book. The
BILLING CODE 4164–01–P
safety or effectiveness (21 CFR 314.162). ‘‘Discontinued Drug Product List’’
A person may petition the Agency to delineates, among other items, drug
determine, or the Agency may products that have been discontinued
DEPARTMENT OF HEALTH AND
determine on its own initiative, whether from marketing for reasons other than
HUMAN SERVICES
a listed drug was withdrawn from sale safety or effectiveness. ANDAs that refer
Food and Drug Administration for reasons of safety or effectiveness. to IZBA (travoprost ophthalmic
This determination may be made at any solution), 0.003 percent, may be
[Docket No. FDA–2015–P–3053]
mstockstill on DSK4VPTVN1PROD with NOTICES
time after the drug has been withdrawn approved by the Agency as long as they
from sale, but must be made prior to meet all other legal and regulatory
Determination That IZBA (Travoprost
approving an ANDA that refers to the requirements for the approval of
Ophthalmic Solution), 0.003 Percent,
listed drug (§ 314.161 (21 CFR 314.161)). ANDAs. If FDA determines that labeling
Was Not Withdrawn From Sale for
FDA may not approve an ANDA that for this drug product should be revised
Reasons of Safety or Effectiveness
does not refer to a listed drug. to meet current standards, the Agency
AGENCY: Food and Drug Administration, IZBA (travoprost ophthalmic will advise ANDA applicants to submit
HHS. solution), 0.003 percent, is the subject of such labeling.
VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1](https://thefederalregister.org/doc/81_FR_4326/page/1.svg)
![Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4311
Dated: January 21, 2016. MD 20993–0002. Information about candidate, within 60 days after the
Leslie Kux, becoming a member of an FDA advisory receipt of the FDA letter, to serve as the
Associate Commissioner for Policy. committee can also be obtained by nonvoting member to represent industry
[FR Doc. 2016–01473 Filed 1–25–16; 8:45 am] visiting FDA’s Web site at http://www. interests for the committee. The
BILLING CODE 4164–01–P
fda.gov/AdvisoryCommittees/ interested organizations are not bound
default.htm. by the list of nominees in selecting a
FOR FURTHER INFORMATION CONTACT: candidate. However, if no individual is
DEPARTMENT OF HEALTH AND Margaret Ames, Center for Devices and selected within 60 days, the
HUMAN SERVICES Radiological Health, Food and Drug Commissioner will select the nonvoting
Administration, 10903 New Hampshire member to represent industry interests.
Food and Drug Administration Ave., Bldg. 66, Rm. 5215, Silver Spring, III. Application Procedure
[Docket No. FDA–2016–N–0001] MD 20993. 301–796–5960, FAX: 301– Individuals may self-nominate and/or
847–8505, email: margaret.ames@ an organization may nominate one or
Request for Nominations on the fda.hhs.gov. more individuals to serve as a nonvoting
National Mammography Quality SUPPLEMENTARY INFORMATION: The industry representative. Contact
Assurance Advisory Committee Agency request nominations for information, a current curriculum vitae,
AGENCY: Food and Drug Administration, nonvoting industry representatives to and the name of the committee of
HHS. the following committee: interest should be sent to the FDA
ACTION: Notice. I. National Mammography Quality Advisory Committee Membership
Assurance Advisory Committee Nomination Portal (see ADDRESSES)
SUMMARY: The Food and Drug within 30 days of publication of this
Administration (FDA) is requesting that The Committee shall advise the Food document (see DATES). FDA will forward
any industry organizations interested in and Drug Administration on: (1) all nominations to the organizations
participating in the selection of Developing appropriate quality expressing interest in participating in
nonvoting industry representatives to standards and regulations for the selection process for the committee.
serve on the National Mammography mammography facilities; (2) developing (Persons who nominate themselves as
Quality Assurance Advisory Committee appropriate standards and regulations nonvoting industry representatives will
(NMQAAC) for the Center for Devices for bodies accrediting mammography not participate in the selection process).
and Radiological Health (CDRH) notify facilities under this program; (3) FDA seeks to include the views of
FDA in writing. FDA is also requesting developing regulations with respect to women and men, members of all racial
nominations for nonvoting industry sanctions; (4) developing procedures for and ethnic groups, and individuals with
representatives to serve on the monitoring compliance with standards; and without disabilities on its advisory
NMQAAC. A nominee may either be (5) establishing a mechanism to committees and, therefore encourages
self-nominated or nominated by an investigate consumer complaints; (6) nominations of appropriately qualified
organization to serve as a nonvoting reporting new developments concerning candidates from these groups.
industry representative. Nominations breast imaging which should be Specifically, in this document,
will be accepted for current and considered in the oversight of nominations for nonvoting
upcoming vacancies effective with this mammography facilities; (7) representatives of industry interests are
notice. determining whether there exists a encouraged from the mammography
shortage of mammography facilities in manufacturing industry.
DATES: Any industry organization
rural and health professional shortage This notice is issued under the
interested in participating in the areas and determining the effects of Federal Advisory Committee Act (5
selection of an appropriate nonvoting personnel on access to the services of U.S.C. app. 2) and 21 CFR part 14,
member to represent industry interests such facilities in such areas; (8) relating to advisory committees.
must send a letter stating that interest to determining whether there will exist a
the FDA by February 25, 2016, (see Dated: January 21, 2016.
sufficient number of medical physicists
sections I and II of this document for Leslie Kux,
after October 1, 1999; and (9)
further details). Concurrently, determining the costs and benefits of
Associate Commissioner for Policy.
nomination materials for prospective compliance with these requirements. [FR Doc. 2016–01487 Filed 1–25–16; 8:45 am]
candidates should be sent to FDA by BILLING CODE 4164–01–P
February 25, 2016. II. Selection Procedure
ADDRESSES: All statements of interest Any industry organization interested
from industry organizations interested in participating in the selection of an DEPARTMENT OF HEALTH AND
in participating in the selection process appropriate nonvoting member to HUMAN SERVICES
of nonvoting industry representative represent industry interests should send
Food and Drug Administration
nomination should be sent to Margaret a letter stating that interest to the FDA
Ames (see FOR FURTHER INFORMATION contact (see FOR FURTHER INFORMATION [Docket No. FDA–2016–N–0001]
CONTACT). All nominations for CONTACT) within 30 days of publication
nonvoting industry representatives may of this document (see DATES). Within the Food and Drug Administration/Xavier
be submitted electronically by accessing subsequent 30 days, FDA will send a University PharmaLink Conference:
Increasing Product Confidence
mstockstill on DSK4VPTVN1PROD with NOTICES
the FDA Advisory Committee letter to each organization that has
Membership Nomination Portal: https:// expressed an interest, attaching a AGENCY: Food and Drug Administration,
www.accessdata.fda.gov/scripts/ complete list of all such organizations; HHS.
FACTRSPortal/FACTRS/index.cfm or by and a list of all nominees along with ACTION: Notice of public conference.
mail to Advisory Committee Oversight their current resumes. The letter will
and Management Staff, Food and Drug also state that it is the responsibility of SUMMARY: The Food and Drug
Administration, 10903 New Hampshire the interested organizations to confer Administration (FDA) Cincinnati
Ave., Bldg. 32, Rm. 5103, Silver Spring, with one another and to select a District, in co-sponsorship with Xavier
VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1](https://thefederalregister.org/doc/81_FR_4326/page/2.svg)
Document Created: 2018-02-02 12:38:20
Document Modified: 2018-02-02 12:38:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Kate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240- 402-1748. | |
| FR Citation | 81 FR 4310 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR