Notice2025-20767
Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams
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Published
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for OCALIVA (obeticholic acid) tablets, 5 milligrams (mg) and 10 mg, held by Intercept Pharmaceuticals, Inc., 305 Madison Ave., Morristown, NJ 07960 (Intercept). In addition, FDA is withdrawing approval of three abbreviated new drug applications (ANDAs) for obeticholic acid tablets, 5 mg and 10 mg, from three separate ANDA holders. Intercept voluntarily requested withdrawal of its NDA, and Apotex, Inc., Lupin Limited, and MSN Laboratories Private Limited voluntarily requested withdrawal of their respective ANDAs, under Sec. 314.150(d) (21 CFR 314.150(d)). The expedited withdrawal procedures set forth in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been waived.
Full Text
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<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52976-52977]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20767]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-5935]
Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval
of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5
Milligrams and 10 Milligrams, and Three Abbreviated New Drug
Applications for Obeticholic Acid Tablets, 5 Milligrams and 10
Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of the new drug application (NDA) for OCALIVA (obeticholic acid)
tablets, 5 milligrams (mg) and 10 mg, held by Intercept
Pharmaceuticals, Inc., 305 Madison Ave., Morristown, NJ 07960
(Intercept). In addition, FDA is withdrawing approval of three
abbreviated new drug applications (ANDAs) for obeticholic acid tablets,
5 mg and 10 mg, from three separate ANDA holders. Intercept voluntarily
requested withdrawal of its NDA, and Apotex, Inc., Lupin Limited, and
MSN Laboratories Private Limited voluntarily requested withdrawal of
their respective ANDAs, under Sec. 314.150(d) (21 CFR 314.150(d)). The
expedited withdrawal procedures set forth in section 506(c)(3)(B) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been waived.
DATES: Approval is withdrawn as of November 24, 2025.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#b8f3d1d5daddcad4c196f4ddd0cadeddd4dcf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="511a383c3334233d287f1d34392337343d35113735307f3939227f363e27">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The applicants and their respective drugs
and applications are included in the following table.
Table 1--NDAs and ANDAs For Which Approval Is Withdrawn
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Application No. Drug Applicant
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NDA 207999................ OCALIVA Intercept
(obeticholic acid) Pharmaceuticals, Inc.,
tablets, 5 mg and 305 Madison Ave.,
10 mg. Morristown, NJ 07960
(Intercept).
ANDA 214862............... Obeticholic Acid Apotex Inc., c/o Apotex
tablets, 5 mg and Corp., 2400 North
10 mg. Commerce Parkway,
Suite 400, Weston, FL
33326 (Apotex).
ANDA 214980............... Obeticholic Acid Lupin Limited, c/o
tablets, 5 mg and Lupin Pharmaceuticals,
10 mg. Inc., 400 Campus Dr.,
Somerset, NJ 08873
(Lupin).
ANDA 215017............... Obeticholic Acid MSN Laboratories
tablets, 5 mg and Private Limited, c/o
10 mg. MSN Pharmaceuticals,
Inc., 20 Duke Rd.,
Piscataway, NJ 08854
(MSN).
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On May 27, 2016, FDA approved NDA 207999 for OCALIVA (obeticholic
acid) tablets, 5 mg and 10 mg, for the treatment of primary biliary
cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in
adults with an inadequate response to UDCA, or as monotherapy in adults
unable to tolerate UDCA, under the accelerated approval pathway
pursuant to section 506(c)(1) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 356(c)(1) and 21 CFR 314.510). The
accelerated approval of OCALIVA (obeticholic acid) tablets, 5 mg and 10
mg, for PBC, was subject to the requirement that Intercept conduct a
postmarketing trial to verify and describe the clinical benefit of
OCALIVA.
On May 26, 2021, FDA approved a safety labeling change to revise
the indication of OCALIVA (obeticholic acid) tablets, 5 mg and 10 mg,
to the treatment of adult patients with PBC without cirrhosis or with
compensated cirrhosis who do not have evidence of portal hypertension,
either in combination with UDCA with an inadequate response to UDCA or
as monotherapy in patients unable to tolerate UDCA.
On May 30, 2023, FDA approved the ANDAs listed in table 1 for
obeticholic acid tablets, 5 mg and 10 mg, for the conditions of use in
the labeling of NDA 207999 for OCALIVA (obeticholic acid) tablets, 5 mg
and 10 mg, the reference listed drugs on which these ANDAs relied.
On August 27, 2025, FDA notified Intercept of a potential problem
with OCALIVA (obeticholic acid) tablets, 5 mg and 10 mg, (NDA 207999),
specifically that the postmarketing trial did not verify clinical
benefit and that OCALIVA-treated PBC patients in the postmarketing
trial who had early-stage disease at baseline had an excess of liver
transplants and deaths. FDA recommended that Intercept request
withdrawal of approval of the NDA 207999 products under Sec.
314.150(d) (21 CFR 314.150(d)). FDA also requested in follow-up
correspondence sent on August 28, 2025, that Intercept waive the
expedited withdrawal procedures set forth in section 506(c)(3)(B) of
the FD&C Act.
On October 1, 2025, FDA notified Apotex of the potential problem
with the drugs and recommended the applicant voluntarily request
withdrawal of approval of ANDA 214862 for obeticholic acid tablets, 5
mg and 10 mg, under Sec. 314.150(d) for the same reasons.
On October 1, 2025, FDA notified Lupin of the potential problem
with the drugs and recommended the applicant voluntarily request
withdrawal of approval of ANDA 214980 for obeticholic acid tablets, 5
mg and 10 mg, under Sec. 314.150(d) for the same reasons.
On October 3, 2025, FDA notified MSN of the potential problem with
the drugs and recommended the applicant voluntarily request withdrawal
of approval of ANDA 215017 for obeticholic acid tablets, 5 mg and 10
mg, under Sec. 314.150(d) for the same reasons.
[[Page 52977]]
On September 10, 2025, Intercept submitted a letter asking FDA to
withdraw approval of NDA 207999 for OCALIVA (obeticholic acid) tablets,
5 mg and 10 mg, under Sec. 314.150(d) and waiving the expedited
withdrawal procedures set forth in section 506(c)(3)(B) of the FD&C
Act. While noting disagreement with the Agency's assessment, Intercept
explained that it respects the Agency's request and is proceeding in
the interest of providing clarity to patients and prescribers.
In a letter dated October 3, 2025, Apotex requested that FDA
withdraw approval of ANDA 214862 under Sec. 314.150(d). In a letter
dated October 10, 2025, Lupin requested that FDA withdraw approval of
ANDA 214980 under Sec. 314.150(d). In a letter dated November 15,
2025, MSN requested that FDA withdraw approval of ANDA 215017 under
Sec. 314.150(d). While noting disagreement with the Agency's
assessment, MSN acknowledged the public health reasons for the Agency's
request and explained that its request for withdrawal is based on
withdrawal of approval of the reference listed drug for ANDA 215017.
For the reasons discussed above, and in accordance with the
applicants' requests, approval of NDA 207999 for OCALIVA (obeticholic
acid) tablets, 5 mg and 10 mg, and ANDAs 214862, 214980, and 215017 for
obeticholic acid tablets, 5 mg and 10 mg, and all amendments and
supplements thereto, is withdrawn under Sec. 314.150(d). Distribution
of Intercept's OCALIVA (obeticholic acid) tablets, 5 mg and 10 mg;
Apotex's obeticholic acid tablets, 5 mg and 10 mg; Lupin's obeticholic
acid tablets, 5 mg and 10 mg; and MSN's obeticholic acid tablets, 5 mg
and 10 mg, into interstate commerce without an approved application is
illegal and subject to regulatory action (see sections 505(a) and
301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d))).
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20767 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
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