Requests that the FDA make a determination that the discontinued FLURBIPROFEN Oral Tablet 100 mg and 50 mg, (NDA 018766) from PHARMACIA AND UPJOHN CO was not discontinued or withdrawn due to safety or efficacy reasons | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-3166

Requests that the FDA make a determination that the discontinued FLURBIPROFEN Oral Tablet 100 mg and 50 mg, (NDA 018766) from PHARMACIA AND UPJOHN CO was not discontinued or withdrawn due to safety or efficacy reasons

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 26, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to Premier Research International, LLC	Mar 26, 2026	--

Keywords

CDER

Citizen Petition

Premier Research International, LLC

Requests that the FDA make a determination that

the discontinued FLURBIPROFEN Oral Tablet 100 mg

and 50 mg, (NDA 018766) from

PHARMACIA AND UPJOHN CO was not discontinued or

withdrawn due to safety or efficacy reasons

Data from Regulations.gov