Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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hydrochloride) capsules in strengths of 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg were not withdrawn from sale for reasons of safety or effectiveness.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- FDA determined the eight strengths of Strattera capsules were not withdrawn for safety or effectiveness reasons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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Obligations
What this law requires
Continue listing STRATTERA (Atomoxetine Hydrochloride) in all 8 strengths (5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg) in the 'Discontinued Drug Product List' section of the Orange Book
Do not initiate withdrawal procedures for any existing ANDAs that refer to STRATTERA (Atomoxetine Hydrochloride) in any of the 8 approved strengths
Approve additional ANDAs for STRATTERA (Atomoxetine Hydrochloride) in all 8 strengths provided they meet all legal and regulatory requirements for ANDA approval
Continue to recognize STRATTERA (Atomoxetine Hydrochloride) NDA 021411 held by Eli Lilly and Co as a valid listed drug reference for purposes of ANDA submissions
Advise ANDA applicants to submit revised labeling if FDA determines that labeling for STRATTERA (Atomoxetine Hydrochloride) should be revised to meet current standards