Pharmaceutical Business review

Watson Wins FDA Approval For Levonorgestrel

Watson has announced that its subsidiary, Watson Laboratories, has received FDA approval for its Abbreviated New Drug Application (ANDA). The approval is meant for its levonorgestrel tablets, 0.75 mg, for women seventeen years and younger. Levonorgestrel is the generic equivalent to Duramed Pharmaceuticals’ PLAN B, which is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure.

The company plans to market the product under the trade name Next Choice and launch the product shortly. Levonorgestrel is approved for prescription use only.

Watson is engaged in the development and distribution of pharmaceuticals of generic products and of brand pharmaceuticals, focused on Urology, women’s health and Nephrology/Medical.