Watson Files Application for Generic FEMCON Femcon
CORONA, Calif., Oct. 3 -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of FEMCON(R) Fe tablets prior to the expiration of patents owned by Warner Chilcott Company, Inc., a subsidiary of Warner Chilcott Limited. Warner Chilcott, filed suit against Watson on October 1, 2007 in the U.S. District Court of New Jersey, seeking to prevent Watson from commercializing its product prior to the expiration of patent number 6,667,050. Warner Chilcott's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of FDA approval of Watson's ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner.
FEMCON(R) Fe (norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets) 0.4mg/35mcg is indicated for the prevention of pregnancy.
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