Glenmark Pharmaceuticals, USA has been granted final approval by the United States Food & Drug Administration (FDA) for the extended-cycle oral contraceptive, levonorgestrel/ethinyl estradiol tablets USP, 0.15 mg/0.03 mg, the AB-rated generic version of Seasonale by Teva Women’s Health.
Seasonale is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending April 2015, the Seasonale market achieved annual sales of approximately $53.7 million.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
The approval marks Glenmark’s 12th oral contraceptive and 2nd extended-cycle oral contraceptive authorized for distribution by the US FDA. Glenmark plans to commence shipping of levonorgestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg immediately.
Glenmark’s current portfolio consists of 99 products authorized for distribution in the US marketplace and 66 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
The use of levonorgestrel and ethinyl estradiol tablets provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins (an additional 9 weeks per year). The convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting.