Opportunity
Federal Register #Docket No. FDA-2025-P-6868
FDA Notice on STRATTERA (Atomoxetine Hydrochloride) Capsules Discontinuation Status
Buyer
Food and Drug Administration
Posted
April 06, 2026
Identifier
Docket No. FDA-2025-P-6868
This FDA regulatory notice addresses the status of STRATTERA (Atomoxetine Hydrochloride) capsules: - Issued by the Food and Drug Administration (FDA), Department of Health and Human Services - Concerns STRATTERA capsules in strengths: 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg - Original manufacturer (OEM): Eli Lilly and Company - FDA determined these capsules were not withdrawn from sale for reasons of safety or effectiveness - Allows continued approval of abbreviated new drug applications (ANDAs) referencing STRATTERA, if all requirements are met - STRATTERA remains listed as discontinued for reasons other than safety or effectiveness - No procurement, solicitation, or award activity is involved; this is a regulatory update impacting generic drug approvals
Description
The FDA has determined that STRATTERA capsules in various dosages were not withdrawn from sale due to safety or effectiveness concerns. This determination allows the FDA to continue approving abbreviated new drug applications (ANDAs) referencing this product. The decision follows a citizen petition and a review of relevant data, confirming no safety or effectiveness issues led to the product's discontinuation. The drug remains listed in the Discontinued Drug Product List for reasons other than safety or effectiveness.