Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale® Tablets. Mylan's partner Famy Care Ltd. 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 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 U.S.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg had U.S. sales of approximately $57.3 million for the 12 months ending December 31, 2014, according to IMS Health.
Currently, Mylan has 273 ANDAs pending FDA approval representing $106.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $31.1 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
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