FDAnews
www.fdanews.com/articles/86728-watson-receives-tentative-approval-for-generic-seasonale

WATSON RECEIVES TENTATIVE APPROVAL FOR GENERIC SEASONALE

May 10, 2006

Watson Pharmaceuticals has received tentative approval today from the FDA on its abbreviated new drug application (ANDA) for levonorgestrel / ethinyl estradiol tablets USP, in 0.15 mg and 0.03 mg.

Levonorgestrel / ethinyl estradiol tablets USP is the generic equivalent to Duramed Pharmaceuticals' Seasonale tablets, which is indicated for prevention of pregnancy.