Notice2026-19968
Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that ISTURISA (osilodrostat) tablets, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for osilodrostat tablets, 10 mg if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 91 Issue 188 (Wednesday, September 30, 2026)</title>
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[Federal Register Volume 91, Number 188 (Wednesday, September 30, 2026)]
[Notices]
[Page 61849]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-P-4574]
Determination That ISTURISA (Osilodrostat) Tablets, 10
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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 ISTURISA (osilodrostat) tablets, 10 milligrams (mg),
was not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for osilodrostat tablets, 10 mg if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Heather Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6269, Silver Spring, MD 20993-0002, 301-
796-3600, <a href="/cdn-cgi/l/email-protection#2b434e4a5f434e59054f4459584e526b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="a6cec3c7d2cec3d488c2c9d4d5c3dfe6c0c2c788ceced588c1c9d0">[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.
ISTURISA (osilodrostat) tablets, 10 mg, is the subject of NDA
212801, held by Recordati Rare Diseases, Inc., and initially approved
on March 6, 2020. ISTURISA is a cortisol synthesis inhibitor indicated
for the treatment of endogenous hypercortisolemia in adults with
Cushing's syndrome for whom surgery is not an option or has not been
curative.
ISTURISA (osilodrostat) tablets, 10 mg, is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Annora Pharma Private Limited submitted a citizen petition dated
April 24, 2026 (Docket No. FDA-2026-P-4574), under 21 CFR 10.30,
requesting that the Agency determine whether ISTURISA (osilodrostat)
tablets, 10 mg, 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 ISTURISA (osilodrostat) tablets, 10 mg, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that ISTURISA
(osilodrostat) tablets, 10 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ISTURISA (osilodrostat) tablets, 10 mg,
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 ISTURISA
(osilodrostat) tablets, 10 mg, 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 ISTURISA (osilodrostat) tablets, 10
mg, 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19968 Filed 9-29-26; 8:45 am]
BILLING CODE 4164-01-P
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