Requests that FDA determine whether ReVia (naltrexone HCl) Tablets, 50 mg, approved under New Drug Application (NDA) number 018932, held by Teva Women’s Health, Inc., has been voluntarily withdrawn for reasons of safety or effectiveness | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-4151

Requests that FDA determine whether ReVia (naltrexone HCl) Tablets, 50 mg, approved under New Drug Application (NDA) number 018932, held by Teva Women’s Health, Inc., has been voluntarily withdrawn for reasons of safety or effectiveness

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensSep 23, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.	Apr 21, 2026	--

Keywords

CDER

Citizen Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA determine whether

ReVia (naltrexone HCl) Tablets, 50 mg, approved

under New Drug Application (NDA) number 018932,

held by Teva Womens Health, Inc., has been

voluntarily withdrawn for reasons of

Data from Regulations.gov