SUPPLEMENTARY INFORMATION:

On May 31, 2018, FDA approved ANDA 208833 for Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg. The reference listed drug (RLD) is Celebrex (celecoxib) capsules, 50 mg, 100 mg, 200 mg, and 400 mg, approved under new drug application (NDA) 020998. According to annual reports filed with the Agency, the drug products approved under ANDA 208833 have not been commercially manufactured since the ANDA's approval in May 2018.

In a letter dated September 16, 2021, FDA notified Amneal that it had significant concerns about the validity and reliability of bioequivalence and bioavailability data generated by a contract research organization that had conducted studies relied on by ANDA 208833 and instructed Amneal to re-conduct bioequivalence studies for ANDA 208833 at an alternate site. The September 16, 2021, letter also informed Amneal that FDA was changing the therapeutic equivalence evaluation code for Amneal's Celecoxib capsules to “BX.” ^[1] In response to multiple inquiries from the Agency, Amneal committed (on October 14, 2021, October 6, 2022, and September 18, 2023) to submitting new bioequivalence studies to enable FDA to make a full evaluation of therapeutic equivalence between Amneal's Celecoxib capsules and the RLD.

On February 22, 2024, FDA requested that Amneal describe its efforts to conduct new bioequivalence studies and provide a timeline for completing and submitting these studies and requested that Amneal agree not to distribute the drug products covered by ANDA 208833 until they were shown to be bioequivalent to the RLD based on bioequivalence studies conducted at an alternate site. On March 18, 2024, Amneal submitted a general correspondence communicating its intent to submit new bioequivalence studies by March 2025 and agreeing not to distribute the drug products covered by ANDA 208833 until these studies were completed and were found to demonstrate bioequivalence to the RLD. In November 2024, Amneal's Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg, approved under ANDA 208833, were moved to the discontinued section of the publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (known generally as the “Orange Book”).

In light of the concerns about the validity and reliability of the bioequivalence data on which ANDA 208833 relied for approval, the absence of new bioequivalence studies demonstrating the bioequivalence of Amneal's Celecoxib capsules to the RLD is a potential problem that is sufficiently serious that the drug should be removed from the market.

As of May 28, 2025, Amneal had not submitted new bioequivalence studies demonstrating the bioequivalence of its Celecoxib capsules to the RLD. Accordingly, FDA suggested that Amneal voluntarily seek withdrawal of approval of ANDA 208833 for Celecoxib capsules under § 314.150(d) (21 CFR 314.150(d)) and note that it was waiving its opportunity for a hearing under § 314.150(a).

In a request for withdrawal of approval submitted June 6, 2025, as amended on June 27, 2025, and July 9, 2025, Amneal requested that FDA withdraw approval of ANDA 208833 for Celecoxib capsules under § 314.150(d) and waived its opportunity for a hearing. Amneal stated that its request for withdrawal of approval was based on Amneal's business decision.

For the reasons discussed above, and in accordance with the applicant's request, approval of ANDA 208833 for Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg, and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg, into interstate commerce without an approved application is illegal and subject to ( printed page 64659) regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

91 FR 64658