Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use by women to prevent pregnancy and for the treatment of acne vulgaris in women at least 14 years of age who have achieved menarche and desire an oral contraceptive for birth control.
In the U.S., Mylan offers more than 20 generic birth control medicines in multiple dosage forms. The products are a part of Mylan’s growing U.S. women’s healthcare portfolio, which includes a vast suite of medicines to help women manage their health across all the stages of their lives.
U.S. sales for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.02 mg was approximately $161 million for the 12 months ending Feb. 28, 2018, according to IQVIA.
Women over 35 years old who smoke should not use Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.
In all, Mylan currently has 204 ANDAs pending FDA approval representing approximately $90.8 billion in annual brand sales, according to IQVIA. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $45.3 billion in annual brand sales, for the 12 months ending Dec. 31, 2017, according to IQVIA.