Document ID: FDA-2022-P-1104-0005
Agency: fda
Document Type: Notice
Title: Determination That ARISTOSPAN (Triamcinolone Hexacetonide) Injectable Suspension, 20 Milligrams/
Milliliter and 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Posted Date: 2023-02-13T05:00Z

[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Pages 9298-9299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02984]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-1104]

Determination That ARISTOSPAN (Triamcinolone Hexacetonide) 
Injectable Suspension, 20 Milligrams/Milliliter and 5 Milligrams/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or 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 ARISTOSPAN (triamcinolone hexacetonide) injectable 
suspension, 20 milligrams (mg)/milliliter (mL) and 5 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withdrawn from sale for reasons of safety or effectiveness.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 hexacetonide injectable 
suspension, 20 mg/mL and 5 mg/mL, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Diana Pomeranz, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 240-
402-4654, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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 FDA's approval of 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.
    ARISTOSPAN (triamcinolone hexacetonide) injectable suspension, 20 
mg/mL and 5 mg/mL, is the subject of NDA 016466, held by Sandoz, Inc., 
and initially approved on July 29, 1969. ARISTOSPAN 20 mg/mL is 
indicated as adjunctive therapy for short-term administration (to tide 
the patient over an acute episode or exacerbation) in acute gouty 
arthritis, acute and subacute bursitis, acute nonspecific 
tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of 
osteoarthritis. ARISTOSPAN 5 mg/mL is indicated for alopecia areata; 
discoid lupus erythematosus; keloids; localized hypertrophic, 
infiltrated, inflammatory lesions of granuloma annulare, lichen planus, 
lichen simplex chronicus (neurodermatitis), and psoriatic plaques; 
necrobiosis lipoidica diabeticorum; and cystic tumors of an aponeurosis 
or tendon (ganglia).
    ARISTOSPAN (triamcinolone hexacetonide) injectable suspension, 20 
mg/mL and 5 mg/mL, is currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book.
    Medexus Pharma, Inc., submitted a citizen petition dated June 9, 
2022 (Docket No. FDA-2022-P-1104), under 21 CFR 10.30, requesting that 
the Agency determine whether ARISTOSPAN (triamcinolone hexacetonide) 
injectable suspension, 20 mg/mL, was withdrawn from sale for reasons of 
safety or effectiveness. Although the citizen petition did not address 
the 5 mg/mL strength, that strength has also been discontinued. On our 
own initiative, we have also determined whether that strength was 
withdrawn for safety or effectiveness reasons.
    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 ARISTOSPAN (triamcinolone hexacetonide) 
injectable

[[Page 9299]]

suspension, 20 mg/mL and 5 mg/mL, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that ARISTOSPAN (triamcinolone hexacetonide) 
injectable suspension, 20 mg/mL and 5 mg/mL, was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of ARISTOSPAN (triamcinolone 
hexacetonide) injectable suspension, 20 mg/mL and 5 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 ARISTOSPAN 
(triamcinolone hexacetonide) injectable suspension, 20 mg/mL and 5 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 
ARISTOSPAN (triamcinolone hexacetonide) injectable suspension, 20 mg/mL 
and 5 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: February 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02984 Filed 2-10-23; 8:45 am]
BILLING CODE 4164-01-P