Watson Pharmaceuticals, Inc. confirmed that it has filed with the FDA an Abbreviated New Drug Application (ANDA) for Drospirenone and Ethinyl Estradiol and Levomefolate Calcium Tablets, 3.0mg/0.02mg/0.451mg and Levomefolate Calcium Tablets, 0.451mg, 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.
For more information, call (800) 272-5525 or visit www.watson.com.