Notice2026-08939
Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
May 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 91 Issue 87 (Wednesday, May 6, 2026)</title>
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[Federal Register Volume 91, Number 87 (Wednesday, May 6, 2026)]
[Notices]
[Pages 24548-24549]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08939]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-P-1306]
Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5
Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of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
determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 milligrams
(mg)/5 milliliters (mL), was not withdrawn from sale for reasons of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: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#98cbecf9fbe1b6d3f9f6fdd8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="85d6f1e4e6fcabcee4ebe0c5e3e1e4abededf6abe2eaf3">[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 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.
DEXAMETHASONE (dexamethasone) elixir, 0.5 mg/5 mL, is the subject
of ANDA 088254, approved on July 27,
[[Page 24549]]
1983, originally held by Wockhardt Bio AG, and currently held by
Pharmobedient Consulting. DEXAMETHASONE is indicated for:
(1) Endocrine disorders: primary or secondary adrenocortical
insufficiency (hydrocortisone or cortisone is the first choice;
synthetic analogs may be used in conjunction with mineralocorticoids
where applicable; in infancy mineralocorticoid supplementation is of
particular importance); congenital adrenal hyperplasia; nonsuppurative
thyroiditis; and hypercalcemia associated with cancer.
(2) Rheumatic disorders: as adjunctive therapy for short-term
administration (to tide the patient over an acute episode or
exacerbation) in psoriatic arthritis; rheumatoid arthritis, including
juvenile rheumatoid arthritis (selected cases may require low-dose
maintenance therapy); ankylosing spondylitis; acute and subacute
bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-
traumatic osteoarthritis; synovitis of osteoarthritis; and
epicondylitis.
(3) Collagen diseases: during an exacerbation or as maintenance
therapy in selected cases of systemic lupus erythematosus and acute
rheumatic carditis.
(4) Dermatologic diseases: pemphigus, bullous dermatitis
herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome),
exfoliative dermatitis, mycosis fungoides, severe psoriasis, and severe
seborrheic dermatitis.
(5) Allergic states: control of severe or incapacitating allergic
conditions intractable to adequate trials of conventional treatment
such as seasonal or perennial allergic rhinitis, bronchial asthma,
contact dermatitis, atopic dermatitis, serum sickness, and drug
hypersensitivity reactions.
(6) Ophthalmic diseases: severe acute and chronic allergic and
inflammatory processes involving the eye and its adnexa, such as
allergic conjunctivitis, keratitis, allergic corneal marginal ulcers,
herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis,
anterior segment inflammation, diffuse posterior uveitis and
choroiditis, optic neuritis, and sympathetic ophthalmia.
(7) Respiratory diseases: symptomatic sarcoidosis, Loeffler's
syndrome not manageable by other means, berylliosis, fulminating or
disseminated pulmonary tuberculosis when used concurrently with
appropriate antituberculous chemotherapy, and aspiration pneumonitis.
(8) Hematologic disorders: idiopathic thrombocytopenic purpura in
adults, secondary thrombocytopenia in adults, acquired (autoimmune)
hemolytic anemia, erythroblastopenia (red blood cell anemia), and
congenital (erythroid) hypoplastic anemia.
(9) Neoplastic diseases: for palliative management of leukemia and
lymphomas in adults, and acute leukemia of childhood.
(10) Edematous states: to induce a diuresis or remission of
proteinuria in the nephrotic syndrome, without uremia, of the
idiopathic type or that due to lupus erythematosus.
(11) Gastrointestinal diseases: to tide the patient over a critical
period of the disease in ulcerative colitis and regional enteritis.
(12) Miscellaneous: tuberculous meningitis with subarachnoid block
or impending block when used concurrently with appropriate
antituberculous chemotherapy, and trichinosis with neurologic or
myocardial involvement.
(13) Diagnostic testing of adrenocortical hyperfunction.
In a letter dated November 16, 2021, Wockhardt Bio AG notified FDA
that DEXAMETHASONE (dexamethasone) elixir, 0.5 mg/5 mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Lachman Consultant Services, Inc. submitted a citizen petition
dated February 4, 2026 (Docket No. FDA-2026-P-1306), under 21 CFR
10.30, requesting that the Agency determine whether DEXAMETHASONE
(dexamethasone) elixir, 0.5 mg/5 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 DEXAMETHASONE (dexamethasone) elixir, 0.5 mg/5
mL, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
DEXAMETHASONE (dexamethasone) elixir, 0.5 mg/5 mL, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of DEXAMETHASONE
(dexamethasone) elixir, 0.5 mg/5 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 DEXAMETHASONE
(dexamethasone) elixir, 0.5 mg/5 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. 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08939 Filed 5-5-26; 8:45 am]
BILLING CODE 4164-01-P
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