Requests that the FDA make a determination that the discontinued Strattera (atomoxetine hydrochloride) 10, 18, 25, 40, 60, 80, and 100 mg capsules (NDA 021411) from Eli Lilly and Co were not discontinued due to safety or efficacy reasons | Federal Regulations · Congress.wiki

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FDA

FDA-2025-P-6868

Requests that the FDA make a determination that the discontinued Strattera (atomoxetine hydrochloride) 10, 18, 25, 40, 60, 80, and 100 mg capsules (NDA 021411) from Eli Lilly and Co were not discontinued due to safety or efficacy reasons

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 9, 2025

Documents

Type	Title	Posted	Comments	Status
Notice	Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness FR Doc: 2026-06661	Apr 6, 2026

Keywords

CDER

Citizen Petition

Rosemont Pharmaceuticals Holdings, Inc.

Requests that the FDA make a determination that

the discontinued Strattera

(atomoxetine hydrochloride) 10, 18, 25, 40, 60,

80, and 100 mg capsules (NDA 021411) from

Eli Lilly and Co were not discontinued due to

Data from Regulations.gov