FDA approves Avion Pharmaceuticals’ Balcoltra

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FDA approves Avion Pharmaceuticals’ Balcoltra

The Food and Drug Administration has approved Avion Pharmaceuticals’ Balcoltra oral contraceptive. The Atlanta-based maker of Prenate prescription prenatal vitamins said that this approval was its first for a new drug it had developed internally.

Balcoltra combines 0.1-mg levonorgestrel tablets, 20-mcg ethinyl estradiol tablets and 36.5-mg ferrous bisglycinate tablets — which the company said was a unique combination on the market.

“Avion is excited to offer our women's health community this oral contraceptive formulation that fills a gap in the current branded options available to women," Avion CEO Art Deas said. “The validity of data related to safety and efficacy for Balcoltra also provides another viable prescribing option for our prescribing community.”

The company said it plans to launch Balcoltra in the spring.

“Avion has always focused on creating a meaningful and long-term supporting role for our women's healthcare prescribers," Avion president Mike Sullivan said. “The Balcoltra approval and forthcoming launch is a monumental event for Avion, allowing us to solidify our commitment to the women's healthcare community.”

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