Oral Contraceptive Balcoltra Gets FDA Approval

Avion announced that the Food and Drug Administration (FDA) has approved Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets), a new oral contraceptive for the prevention of pregnancy.

Balcoltra is the only branded contraceptive that combines levonorgestrel 0.1mg and ethinyl estradiol 20mcg with ferrous bisglycinate 36.5mg. Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Balcoltra will be available as a blister pack containing 28 tablets; 21 are active and 7 are inactive. The product contains tartrazine which may cause allergic-type reactions in certain susceptible individuals.

Balcoltra is anticipated to launch in Spring 2018.

January 17, 2018

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