# 2026-16248: FDA: Baclofen Oral Solution Safe, Generics Can Proceed

2026-16248, Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-10, effective 2026-08-10; PRIA reads it as touching household money (as of 2026-08-17).

- Canonical: https://policyrisk.com/federal-register/2026-16248
- As of: 2026-08-17
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16248
- Title: Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 51492
- Published: 2026-08-10
- Effective: 2026-08-10
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-17

## In one line

FDA: Baclofen Oral Solution Safe, Generics Can Proceed

## Summary

The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

## Effects PRIA read

- Generics Can Still Reference OZOBAX: benefit, medium. The FDA determined on August 10, 2026 that OZOBAX (baclofen) oral solution, 5 mg/5 mL (originally approved September 18, 2019 and discontinued by the holder on October 13, 2023) was not withdrawn for reasons of safety or effectiveness. FDA will not begin procedures to withdraw approval of ANDAs tha…
- Discontinued but Not Pulled for Safety: benefit, medium. The FDA has concluded that OZOBAX (baclofen) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. The product will remain in the Orange Book's "Discontinued Drug Product List" and FDA may continue approving ANDAs that refer to this product if they meet all l…

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## Sources
- [2026-16248 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/10/2026-16248/determination-that-ozobax-baclofen-oral-solution-5-milligrams5-milliliters-was-not-withdrawn-from)
- [2026-16248 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-10/pdf/2026-16248.pdf)

## Related
- [Previous: 2026-16247, Determination of Regulatory Review Period for Purposes of Patent Extension; BRI…](https://policyrisk.com/federal-register/2026-16247)
- [Next: 2026-16253, Collection of Information Under Review by Office of Management and Budget; OMB…](https://policyrisk.com/federal-register/2026-16253)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16248 (as of 2026-08-17).