The US FDA has issued marketing approval for Lupin Pharmaceuticals' Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1mg / 0.02mg, the combined oral contraceptive.
Levonorgestrel and Ethinyl Estradiol Tablets are the generic equivalent to Watson Laboratories' Lutera 28 tablets indicated to prevent pregnancy in women.
Lupin is expected to begin the product marketing soon.
The safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets were established in a multicenter open-label trial conducted for 12 months.
Around 2,185 women between 18 to 41 years of age participated in the study, completing the equivalent of 20,937 28-day cycles of exposure.
Combination of oral contraceptives works by inhibiting ovulation while other probable mechanisms include cervical mucus changes and endometrial changes, which inhibit sperm penetration and reduce the chance of implantation respectively.
