# 2026-06661: FDA Confirms Strattera Safe for Generic ADHD Treatment Production

2026-06661, Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration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 2026-04-06, effective 2026-04-06; PRIA reads it as touching household money (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2026-06661
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-06661
- Title: Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 17285
- Published: 2026-04-06
- Effective: 2026-04-06
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Confirms Strattera Safe for Generic ADHD Treatment Production

## Summary

The FDA confirmed that STRATTERA capsules in all strengths weren’t pulled from the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions, helping patients access affordable ADHD treatment without interruption. No changes in price or availability are expected, so everyone can breathe easy!

## Abstract

The Food and Drug Administration (FDA or Agency) has determined that STRATTERA (atomoxetine hydrochloride) capsules 5 milligrams, 10 milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, were not withdrawn from sale for reasons of safety or effectiveness.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 Eligible for ANDA Approval: benefit, medium. The FDA found that STRATTERA (atomoxetine hydrochloride) capsules — 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg — were not withdrawn from sale for reasons of safety or effectiveness. Because of this, FDA will not begin procedures to withdraw approval of ANDAs that refer to this produ…

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## Sources
- [2026-06661 on federalregister.gov](https://www.federalregister.gov/documents/2026/04/06/2026-06661/determination-that-strattera-atomoxetine-hydrochloride-capsules-5-milligrams-10-milligrams-18)
- [2026-06661 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-04-06/pdf/2026-06661.pdf)

## Related
- [Previous: 2026-06660, Electronic Submission of Postmarketing Individual Case Safety Reports to the Fo…](https://policyrisk.com/federal-register/2026-06660)
- [Next: C1-2026-05238, Submission for OMB Review; 30-Day Comment Request; Hazardous Waste Worker Train…](https://policyrisk.com/federal-register/C1-2026-05238)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-06661 (as of 2026-06-08).