Mylan N.V., a global pharmaceutical company, launched guanfacine extended-release tablets, 1 mg, 2 mg, 3 mg, and 4 mg, which is the generic version of Shire's Intuniv tablets in US markets. It is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.The company received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Guanfacine extended-release tablets, 1 mg, 2 mg, 3 mg, and 4 mg, had US sales of approximately $804.9 million and levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg and ethinyl estradiol tablets USP, 0.01 mg, had US sales of approximately $160.7 million for the 12 months ending March 31, 2015, According to IMS Health.
Mylan also announced the US launch of levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg and ethinyl estradiol tablets USP, 0.01 mg, which is the generic version of Teva's Seasonique tablets. Mylan's partner Famy Care Ltd. got final approval for the product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).
Recently, Mylan has 271 ANDAs pending FDA approval of $106 billion in annual brand sales. 47 of these pending ANDAs are potential first-to-file opportunities, representing $32 billion in annual brand sales.
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