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news.KV Pharmaceutical has entered into an amendment to the existing asset purchase agreement with Hologic to secure the full US and worldwide rights to Gestiva, subject to the terms and conditions set forth in the amendment.
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Upon approval by the FDA, Gestiva will be the first and only FDA-approved treatment for the prevention of preterm birth in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past.
David Van Vliet, interim CEO at KV Pharmaceutical, said: “While our highest priority is to demonstrate cGMP compliance so we can return our approved products to market, we believe Gestiva will be an important addition to our women’s health franchise and are pleased we could reach this agreement with Hologic. We will continue to assist Hologic in completing the steps to obtain FDA approval of this socially valuable product.”