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Monday 31 July 2006
FDA Approves Desogestrel and Ethinyl Estradiol Tablets
Watson Pharmaceuticals, Inc. (NYSE:WPI) , a leading specialty pharmaceutical company has received final approval from the United States (U.S.)
Watson Pharmaceuticals, Inc. (NYSE:WPI) , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application for desogestrel and ethinyl estradiol tablets USP, 0.15mg / 0.03mg, a generic version of Ortho-McNeil's Ortho-Cept(R) and Organon's Desogen(R) products which are indicated for the prevention of pregnancy.
The Company intends to initiate shipments of the product immediately. For the 12-months ending March 2005, desogestrel and ethinyl estradiol tablets USP, 0.15mg / 0.03mg market had total U.S. sales of approximately $180 million, according to IMS Health data.