FDA Confirms Strattera Safe for Generic ADHD Treatment Production
Published Date: 4/6/2026
Notice
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!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generics Eligible for ANDA Approval
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STRATTERA (atomoxetine hydrochloride) capsules — 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg — were not withdrawn from sale for reasons of safety or effectiveness.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 product and may continue approving new ANDAs that reference it as long as they meet legal and regulatory requirements.
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