Watson Pharmaceuticals announced that it has received final approval from the FDA for its abbreviated new drug application for levonorgestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg. The drug is the generic equivalent to Barr Pharmaceuticals' Seasonale extended-cycle oral contraceptive, which is indicated for prevention of pregnancy. Watson intends to launch the product immediately under the trade name Quasense.
In addition, Barr announced it is launching its own generic version of Seasonale under the trade name Jolessa. Barr's three-year new product exclusivity period for Seasonale expired Sept. 5.
For the 12-months ending June, Seasonale had total U.S. sales of approximately $110 million, according to IMS Health data.