Watson Pharmaceuticals, Inc.
WPI today confirmed that its subsidiary, Watson Laboratories, Inc.,
filed an Abbreviated New Drug Application with the U.S. Food and Drug
Administration (FDA) seeking approval to market Drospirenone and Ethinyl
Estradiol and Levomefolate Calcium Tablets, 3.0 mg/0.02 mg/0.451 mg and
Levomefolate Calcium Tablets, 0.451 mg. Watson's ANDA product is a generic
version of Bayer HealthCare Pharmaceuticals Inc.'s Beyaz®. Beyaz® is an oral
contraceptive indicated for use by women to prevent pregnancy, treat symptoms
of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral
contraceptive for contraception, treat moderate acne for women at least 14
years old only if the patient desires an oral contraceptive for birth control,
and raise folate levels in women who choose to use an oral contraceptive for
contraception.
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