Notice2025-12444
Determination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
July 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 90 Issue 126 (Thursday, July 3, 2025)</title>
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[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29556-29557]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12444]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0333]
Determination That SYNDROS (Dronabinol) Solution, 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Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or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, Agency, or we) has
determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/
milliliter (mL), was not withdrawn from sale for reasons of safety or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 SYNDROS (dronabinol) solution, 5 mg/
mL, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#d190a6beff90a3b2b9b0bca1bebfb6fc96a3b0a891b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="a0e1d7cf8ee1d2c3c8c1cdd0cfcec78de7d2c1d9e0c6c4c18ec8c8d38ec7cfd6">[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.
SYNDROS (dronabinol) solution, 5 mg/mL, is the subject of NDA
205525, held by Chartwell Scheduled, LLC, and initially approved on
July 1, 2016. SYNDROS is indicated in adults for the treatment of
anorexia associated with weight loss in patients with acquired immune
deficiency syndrome; and of nausea and vomiting associated with cancer
chemotherapy in patients who have failed to respond adequately to
conventional antiemetic treatments.
SYNDROS (dronabinol) solution, 5 mg/mL, is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc. submitted a citizen petition
dated January 20, 2025 (Docket No. FDA-2025-P-0333), under 21 CFR
10.30, requesting that the Agency determine whether SYNDROS
(dronabinol) solution, 5 mg/mL, was withdrawn from sale for reasons of
safety or effectiveness.
[[Page 29557]]
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 SYNDROS (dronabinol) solution, 5 mg/mL, was
not withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
SYNDROS (dronabinol) solution, 5 mg/mL, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of SYNDROS (dronabinol) solution, 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 SYNDROS (dronabinol)
solution, 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 SYNDROS (dronabinol) solution, 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: June 30, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12444 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P
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