Requests that the require any application submitted under sections 505(j) or 505(b)(2) of the FD&C Act that references AMVUTTRA® as the RLD to include sufficient evidence to demonstrate pharmaceutical equivalence7 and to establish that the proposed product can be expected to have the same clinical effect and safety profile as AMVUTTRA® under the conditions of use described in the labeling. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7229

Requests that the require any application submitted under sections 505(j) or 505(b)(2) of the FD&C Act that references AMVUTTRA® as the RLD to include sufficient evidence to demonstrate pharmaceutical equivalence7 and to establish that the proposed product can be expected to have the same clinical effect and safety profile as AMVUTTRA® under the conditions of use described in the labeling.

Documents

Comments

Key Dates

Comment Period OpensJun 30, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Tab 6	Jun 30, 2026	--

Keywords

CDER

Citizen Petition

Alnylam Pharmaceuticals Inc

require any application submitted

under sections 505j or 505b2 of the FD and C

Act that references AMVUTTRA®

as the RLD to include sufficient evidence

to demonstrate pharmaceutical equivalence

Data from Regulations.gov