FDA approves Watson's ANDA for generic Yaz oral contraceptive

Nov 29 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Vestura(TM) (3 mg drospirenone and 0.02 mg ethinyl estradiol), a generic version of Bayer's Yaz(R) oral contraceptive product.  Watson is currently involved in patent litigation with Bayer concerning this product. 

Yaz(R) had total U.S. sales of $173 million for the twelve months ending September 30, 2011, according to IMS Health. Watson's Vestura(TM) is indicated for the prevention of pregnancy and for the treatment of moderate acne in women at least 14 years old only if the patient desires an oral contraceptive for birth control.