Executive Summary

 

NDA: 21-239 Submission Dates:

Brand Name: AsleraTM Original NDA: 09/26/00

Generic Name: Prasterone Original Amendment N-BB: 02/09/01

Dosage Form: Capsules

Strength: 50 mg

Applicant: Genelabs Technologies

Redwood City, CA

OCPB Division: DPEIII

Reviewer: Abimbola Adebowale Ph.D.

Team Leader: Dennis Bashaw Pharm.D.


  1. Introduction and Background

Genelabs Technologies, Inc. is seeking the approval of AsleraTM, for the following proposed indications:1) Improvement in disease activity and/or its symptoms in women with mild to moderate Systemic Lupus Erythematosus (SLE) and, 2) Reduction of corticosteroid requirements in steroid-dependent women with mild to moderate SLE.