FDA Withdraws Three ANDAs From Egis Pharmaceuticals and Ambix Laboratories

Content

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs)
from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required
annual reports for those ANDAs.

DATES:

Approval is withdrawn as of April 24, 2026.

FOR FURTHER INFORMATION CONTACT:

Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75,
Rm. 1676, Silver Spring, MD 20993-0002, 301-796-3471, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

The holder of an approved application to market a new drug for human use is required to submit annual reports to FDA concerning
its approved application in accordance with §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98).

In the
Federal Register
of December 29, 2025 (90 FR 60724), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw
approval of three ANDAs because the holders of these ANDAs had repeatedly failed to submit the required annual reports for
these ANDAs. The holders of these ANDAs did not respond to the NOOH. Failure to file a written notice of participation and
request for hearing as required by § 314.200 (21 CFR 314.200) constitutes a waiver of the opportunity for hearing by the holders
of the ANDAs concerning the proposal to withdraw approval of the ANDAs and a waiver of any contentions concerning the legal
status of the drug products. Therefore, FDA is withdrawing approval

of the three applications listed in Table 1 of this document.

FDA finds that the holders of the ANDAs listed in Table 1 have repeatedly failed to submit reports required by §§ 314.81 and
314.98. In addition, under § 314.200, FDA finds that the holders of the ANDAs have waived the opportunity for a hearing and
any contentions concerning the legal status of the drug products. Therefore, based on these findings and pursuant to the authority
under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), approval of the ANDAs listed in Table
1 and all amendments and supplements thereto, is hereby withdrawn as of April 24, 2026.

Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-08020 Filed 4-23-26; 8:45 am] BILLING CODE 4164-01-P

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