Federal Register Notice: FDA has determined the regulatory review period for Bayer Healthcare’s Beyaz is 1,271 days for extending a patent which claims the human drug product. FDA recently approved Beyaz (drospirenone, ethinyl estradiol, and levomefolate calcium) for use in women to: prevent pregnancy; treat symptoms of premenstrual dysphoric disorder 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. To view this notice, click here.