FDA Greenlights Generics for ADHD Drug Strattera Without Safety Concerns
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 delays. 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.
Generic ADHD Drug Approvals Continue
On April 6, 2026, FDA determined that STRATERA (atomoxetine hydrochloride) capsules — 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg — were not withdrawn from sale for reasons of safety or effectiveness.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 that determination, FDA will not begin procedures to withdraw approval of ANDAs that refer to STRATTERA and may continue to approve new ANDAs that meet legal and regulatory requirements, allowing generic manufacturers to seek approval and helping patients access affordable ADHD treatment.
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