81 FR 35362 - Determination That TRIVARIS (Triamcinolone Acetonide) Injectable Suspension, 80 Milligrams/Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 106 (June 2, 2016)

The Food and Drug Administration (FDA or Agency) has determined that TRIVARIS (triamcinolone acetonide) injectable suspension, 80 milligrams/milliliters (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for triamcinolone acetonide injectable suspension, 80 mg/mL, if all other legal and regulatory requirements are met.

[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35362-35363]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-0378]


Determination That TRIVARIS (Triamcinolone Acetonide) Injectable 
Suspension, 80 Milligrams/Milliliters, Was Not Withdrawn From Sale for 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

[[Page 35363]]

determined that TRIVARIS (triamcinolone acetonide) injectable 
suspension, 80 milligrams/milliliters (mg/mL), was not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
triamcinolone acetonide injectable suspension, 80 mg/mL, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977.

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, 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.
    TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, 
is the subject of NDA 22-220, held by Allergan, and initially approved 
on June 16, 2008. TRIVARIS is indicated for sympathetic ophthalmia, 
temporal arteritis, uveitis, and ocular inflammatory conditions 
unresponsive to topical corticosteroids. TRIVARIS (triamcinolone 
acetonide) injectable suspension, 80 mg/mL, is currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    The Weinberg Group submitted a citizen petition dated January 28, 
2016 (Docket No. FDA-2016-P-0378), under 21 CFR 10.30, requesting that 
the Agency determine whether TRIVARIS (triamcinolone acetonide) 
injectable suspension, 80 mg/mL, 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 TRIVARIS (triamcinolone acetonide) injectable 
suspension, 80 mg/mL, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that TRIVARIS (triamcinolone acetonide) 
injectable suspension, 80 mg/mL, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of TRIVARIS (triamcinolone acetonide) 
injectable suspension, 80 mg/mL, 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 TRIVARIS 
(triamcinolone acetonide) injectable suspension, 80 mg/mL, 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 TRIVARIS 
(triamcinolone acetonide) injectable suspension, 80 mg/mL, 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: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12949 Filed 6-1-16; 8:45 am]
 BILLING CODE 4164-01-P