Mylan NV, a global pharmaceutical company, launched levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg, generic version of Teva's Seasonale tablets, in the US.
Mylan's partner Famy Care Ltd received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Mylan's immediate shipment of levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg represents the company's tenth oral contraceptive product launch in the US.
Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg had US sales of approximately USD 57.3 million for the 12 months ended December 31, 2014, according to IMS Health.
Currently, Mylan has 273 ANDAs pending FDA approval representing USD 106.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing USD 31.1 billion in annual brand sales, for the 12 months ended December 31, 2014, according to IMS Health.