Mylan Launches Generic Contraceptive and ADHD Drugs

Mylan N.V. has launched in the US, 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. 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.

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, and as reported by Mylan.

Mylan N.V. also has launched in the US guanfacine extended-release tablets, 1 mg, 2 mg, 3 mg, and 4 mg, which is the generic version of Shire’s Intuniv tablets. Mylan received final approval from the FDA for its ANDA for this product, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

Guanfacine extended-release tablets, 1 mg, 2 mg, 3 mg, and 4 mg, had U.S. sales of approximately $804.9 million for the 12 months ending March 31, 2015, according to IMS Health, and as reported by Mylan.

Earlier this month, Teva Pharmaceutical Industries also launched a generic version of guanfacine extended-release tablets in the US.

Source: Mylan (contraceptive) and Mylan (guanfacine)

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