Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Ciplas product an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4112

Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Ciplas product an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant

Documents

Comments

Description

Open

Key Dates

Comment Period OpensApr 21, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Exhibit 52 - Nakai - Detection of Hydrogen Atoms Using Only 3D ED_MicroED and Contribution to Structure Determining Salts or Cocry	Apr 21, 2026	--

Keywords

CDER

Citizen Petition

Gilead Sciences, Inc.

Requests that the FDA take the following actions

1. Rescind FDA's decision to file Cipla's

section 505(b)(2) application for an apparent

duplicate of DESCOVY; and

2. Refuse to grant Cipla's product an

Data from Regulations.gov