[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Pages 15249-15250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-4158]
Determination That DECADRON (Dexamethasone Sodium Phosphate)
Solution/Drops, Equivalent to 0.1 Percent Phosphate, Was Not Withdrawn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, Agency, or we) has
determined that DECADRON (dexamethasone sodium phosphate) solution/
drops, equivalent to (EQ) 0.1 percent phosphate, was not withdrawn from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: Michelle Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-
402-0374, [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
[[Page 15250]]
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.
DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1
percent phosphate, is the subject of NDA 011984, held by Merck and Co.,
Inc., and initially approved on September 2, 1959. DECADRON is
indicated for the treatment of the following conditions: Ophthalmic:
Steroid responsive inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea, and anterior segment of the globe, such as
allergic conjunctivitis, acne rosacea, superficial punctate keratitis,
herpes zoster keratitis, iritis, cyclitis, selected infective
conjunctivitis when the inherent hazard of steroid use is accepted to
obtain an advisable diminution in edema and inflammation; corneal
injury from chemical or thermal burns, or penetration of foreign
bodies; and Otic: Steroid responsive inflammatory conditions of the
external auditory meatus, such as allergic otitis externa, selected
purulent and nonpurulent infective otitis externa when the hazard of
steroid use is accepted to obtain an advisable diminution in edema and
inflammation.
DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1
percent phosphate, is currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
Odin Pharmaceuticals, LLC, submitted a citizen petition dated
August 30, 2024 (Docket No. FDA-2024-P-4158), under 21 CFR 10.30,
requesting that the Agency determine whether DECADRON (dexamethasone
sodium phosphate) solution/drops, EQ 0.1 percent phosphate, 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 DECADRON (dexamethasone sodium phosphate)
solution/drops, EQ 0.1 percent phosphate, was not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that DECADRON (dexamethasone sodium
phosphate) solution/drops, EQ 0.1 percent phosphate, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of DECADRON (dexamethasone
sodium phosphate), solution/drops, EQ 0.1 percent phosphate, 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 DECADRON
(dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent
phosphate, 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: March 31, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06046 Filed 4-8-25; 8:45 am]
BILLING CODE 4164-01-P