Notice2023-02984
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(Triamcinolone Hexacetonide) Injectable Suspension, 20 Milligrams/Milliliter and 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
February 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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ARISTOSPAN (triamcinolone hexacetonide) injectable suspension, 20 milligrams (mg)/milliliter (mL) and 5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 88 Issue 29 (Monday, February 13, 2023)</title>
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[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Pages 9298-9299]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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, <a href="/cdn-cgi/l/email-protection#42062b232c236c122d2f2730232c38022426236c2a2a316c252d34"><span class="__cf_email__" data-cfemail="56123f3738377806393b332437382c16303237783e3e2578313920">[email protected]</span></a>.
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
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