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.
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.