Watson Pharmaceuticals, Inc. has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for levonorgestrel ethinyl estradiol tablets USP, 0.15 mg / 0.03 mg. Levonorgestrel/ethinyl estradiol tablets, USP, is the generic equivalent to Duramed Pharmaceuticals' seasonale extended-cycle oral contraceptive, which is indicated for prevention of pregnancy.
The company intends to launch the product immediately under the trade name QUASENSE. For the 12-months ending June 2006, seasonale had total US sales of approximately $110 million, according to IMS Health data.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.