[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4310-4311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01473]


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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Percent, Was Not Withdrawn From Sale for Reasons of Safety or 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.

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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was not withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of safety or effectiveness (21 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