[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Page 71044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29484]



[[Page 71044]]

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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0.004%, Was Not Withdrawn From Sale for Reasons of Safety or 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.

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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TRAVATAN (travoprost ophthalmic solution), 0.004%, was not withdrawn 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