Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The FDA has determined that Strattera (atomoxetine hydrochloride) capsules in strengths of 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg were not withdrawn from sale for reasons of safety or effectiveness. This decision follows Eli Lilly's discontinuation notice in August 2025 and a citizen petition from Rosemont Pharmaceuticals. As a result, the FDA will keep the product in the Discontinued section of the Orange Book and will not initiate withdrawal of any existing ANDAs referencing this NDA. Additional generic applications may continue to be approved if they meet all regulatory requirements. The drug remains indicated for the treatment of ADHD.
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Key Changes
- FDA determined the eight strengths of Strattera capsules were not withdrawn for safety or effectiveness reasons
- Product remains listed in the Discontinued Drug Product List section of the Orange Book
- FDA will not initiate withdrawal procedures for any approved ANDAs referencing NDA 021411
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