BRIEF—Avion Pharma's first oral contraceptive NDA approved

USA-based Avion Pharmaceuticals, the makers of the Prenate line of prescription prenatal vitamins, says it has received approval of its New Drug Application (NDA) for the oral contraceptive Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets), the company's first internally developed NDA.

Avion expects to commercially launch this new oral contraceptive to the prescribing community in spring 2018.

The approval of Balcoltra, the only branded oral contraceptive combining 0.1mg levonorgestrel, 20mcg ethinyl estradiol tablets and ferrous bisglycinate tablets 36.5mg, marks a milestone for Avion Pharmaceuticals and a win for the women's health category by allowing women to have access to a clinically effective form of oral contraception for pregnancy prevention, the company stated.