Another Generic Seasonale Approved

Glenmark Pharmaceuticals’ levonorgestrel/ethinyl estradiol tablets, a generic version of Teva’s Seasonale extended-cycle birth control, have been cleared by the FDA and will begin shipping immediately.

The tablets are indicated for women who choose to use oral contraceptives to protect against pregnancy.

Women who take levonorgestrel/ethinyl estradiol tablets receive more hormonal exposure on an annual basis and have fewer menstrual cycles per year than those taking conventional monthly oral contraceptives.

Noted side effects with levonorgestrel/ethinyl estradiol tablets include nausea, vomiting, headache, and stomach cramping. Some vaginal bleeding may occur between menstrual cycles, especially in the first few months of taking the medication.

For the 12-month period ending in April 2015, Seasonale had annual US sales of approximately $53.7 million, according to IMS Health.

Mylan began shipping its generic version of Seasonale in May.