USFDA grants Glenmark permission to market oral contraceptive pill

The US Food & Drug Administration (USFDA) on June 15, 2015 granted final approval to Glenmark Pharmaceuticals for marketing the extended-cycle oral contraceptive pill - levonorgestrel/ethinyl estradiol tablets USP, 0.15mg/0.03mg – which is a generic version of Seasonale by Teva Women’s Health.
 
Seasonale is indicated for the prevention of pregnancy in women who chose to use oral contraceptives as a method of contraception, said Glenmark in a press release. According to IMS Health, Seasonale achieved annual sales of approximately $53.7 million for the 12 month period ending April 2015.
 
With this, Glenmark has received approvals for 12 oral contraceptive and two extended-cylce oral contraceptive from the US drug regulator.