# 2025-00743: Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications

2025-00743, Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications, is a Federal Register notice from an unnamed agency published 2025-01-15, effective 2025-02-14 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-00743
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-00743
- Title: Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications
- Type: Notice
- Agencies: unknown
- Citation: unknown
- Published: 2025-01-15
- Effective: 2025-02-14
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## Summary

The FDA is officially pulling the plug on 12 drug approvals because the companies stopped selling these medicines. This change kicks in on February 14, 2025, and it mainly affects the drug makers and anyone tracking these products. Don’t worry—companies can ask to bring these drugs back if they want to in the future!

## Abstract

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

## Effects PRIA read

- FDA Withdraws 12 Drug Approvals: cost, medium. The FDA is withdrawing approval of 12 New Drug Applications (NDAs) as of February 14, 2025, because the applicants told FDA the products are no longer marketed and asked for withdrawal. The withdrawal applies to the entire listed applications (all strengths and forms) and is without prejudice to re…
- Existing Inventory Can Still Be Dispensed: benefit, low. Drug products listed in the withdrawn NDAs that are in inventory on February 14, 2025, may continue to be dispensed until those inventories are depleted or the products reach their expiration dates, or otherwise become violative, whichever occurs first. This allows current stock to be used after th…
- Selling These Drugs Without Approval Is Prohibited: cost, medium. After February 14, 2025, introducing or delivering for introduction into interstate commerce any of the listed products without an approved NDA will violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Companies, distributors, or others who m…

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## Sources
- [2025-00743 on federalregister.gov](https://www.federalregister.gov/documents/2025/01/15/2025-00743/teva-branded-pharmaceutical-products-randd-inc-et-al-withdrawal-of-approval-of-12-new-drug)
- [2025-00743 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-01-15/pdf/2025-00743.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-00743 (as of 2026-06-08).