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FDA Approves Balcoltra

Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive

ATLANTA, Jan. 17, 2018 /PRNewswire/ -- Avion Pharmaceuticals, LLC, the makers of the PrenateĀ® line of prescription prenatal vitamins, 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 0.1 mg levonorgestrel, 20 mcg ethinyl estradiol tablets and ferrous bisglycinate tablets 36.5 mg, 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.

"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," stated Art Deas, CEO of Avion. "The validity of data related to safety and efficacy for Balcoltra also provides another viable prescribing option for our prescribing community," added Deas.

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

About Avion Pharmaceuticals, LLC

Avion Pharmaceuticals, LLC is a specialty pharmaceutical company formed to develop and market a portfolio of innovative pharmaceutical products in the Women's Heath therapeutic category. Avion Pharmaceuticals focuses on identifying opportunities to acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfill unmet medical needs. For additional information about Avion Pharmaceuticals please contact the company at 678-325-5188. For more information, visit www.prenate.com.

SOURCE Avion Pharmaceuticals, LLC

Posted: January 2018

Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) FDA Approval History

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