Request that the FDA determine whether the Reference Listed Drug (RLD) VELTASSA (PATIROMER SORBITEX CALCIUM) Oral Powder, Eq 25.2 gm Base/Packet; under New Drug Application (NDA) 205739 held by VIFOR PHARMA INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5017

Request that the FDA determine whether the Reference Listed Drug (RLD) VELTASSA (PATIROMER SORBITEX CALCIUM) Oral Powder, Eq 25.2 gm Base/Packet; under New Drug Application (NDA) 205739 held by VIFOR PHARMA INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMay 7, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Citizen Petition from Strides Pharma, Inc.	May 7, 2026	--

Keywords

CDER

Citizen Petition

Strides Pharma, Inc.

determine whether the

Reference Listed Drug (RLD)

VELTASSA (PATIROMER SORBITEX CALCIUM)

Oral Powder, Eq 25.2 gm Base/Packet

under New Drug Application (NDA) 205739

Data from Regulations.gov