Requests that the FDA declare that Semaglutide Injection, 1mg/1.5 mL (0.68 mg/mL), 2mg/1.5 mL (1.34 mg/mL), 4mg/3 mL (1.34 mg/mL), 6.8mg/3 mL (2.27 mg/mL), 9.6mg/3 mL (3.2 mg/mL) in pre-filled, disposable and multi-dose pen injector, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-7376

Requests that the FDA declare that Semaglutide Injection, 1mg/1.5 mL (0.68 mg/mL), 2mg/1.5 mL (1.34 mg/mL), 4mg/3 mL (1.34 mg/mL), 6.8mg/3 mL (2.27 mg/mL), 9.6mg/3 mL (3.2 mg/mL) in pre-filled, disposable and multi-dose pen injector, is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 29, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to The WhiteOak Group, LLC (on behalf of Hybio Pharmaceutical Co., Ltd.)	Jul 16, 2026	--

Keywords

CDER

Suitability Petition

The WhiteOak Group, LLC

on behalf of Hybio Pharmaceutical Co., Ltd.

Requests that the FDA declare that

Semaglutide Injection, 1mg/1.5 mL (0.68 mg/mL),

2mg/1.5 mL (1.34 mg/mL), 4mg/3 mL (1.34 mg/mL),

6.8mg/3 mL (2.27 mg/mL), 9.6mg/3 mL (3.2 mg/mL)

Data from Regulations.gov