[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43384-43385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-1108]


Determination That TIMOPTIC (Timolol Maleate Ophthalmic 
Solution), 0.25 Percent and 0.5 Percent, Was Not Withdrawn From Sale 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 TIMOPTIC (timolol maleate ophthalmic solution), 0.25 
percent and 0.5 percent, was not withdrawn from sale for reasons of 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 this drug product, and it will allow 
FDA to continue to approve ANDAs that refer to the product as long as 
they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510.

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 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, 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).
    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.
    TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 
0.5 percent, is the subject of NDA 018086, held by Aton Pharma, Inc. 
and initially approved on August 17, 1978. TIMOPTIC is indicated for 
the treatment of elevated intraocular pressure in patients with ocular 
hypertension or open-angle glaucoma.
    TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 
0.5 percent, is currently listed in the ``Discontinued Drug Product 
List'' section of the Orange Book. Orbicular Pharmaceutical 
Technologies, Pvt. Ltd., submitted a citizen petition dated February 
22, 2017 (Docket No. FDA-2017-P-1108), under 21 CFR 10.30, requesting 
that the Agency determine whether TIMOPTIC (timolol maleate ophthalmic 
solution), 0.25 percent and 0.5 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 TIMOPTIC (timolol maleate ophthalmic 
solution), 0.25 percent and 0.5 percent, was not withdrawn for reasons 
of safety or effectiveness. The petitioner has identified no data or 
other information suggesting that this drug product was

[[Page 43385]]

withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of TIMOPTIC 
(timolol maleate ophthalmic solution), 0.25 percent and 0.5 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 drug product was withdrawn 
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list TIMOPTIC (timolol 
maleate ophthalmic solution), 0.25 percent and 0.5 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. FDA will not begin procedures to withdraw 
approval of approved ANDAs that refer to this drug product. Additional 
ANDAs for this drug product may also 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: September 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19610 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P