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Adeza
Adeza submits new drug application for Gestiva to prevent preterm births
June 2nd, 2006
Adeza (ADZA) announced the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Gestiva, the company's drug candidate to prevent preterm birth in women with a history of preterm delivery. Adeza has requested Priority Review for the Gestiva NDA that, if granted, would set a 6 month goal for review by the FDA. Adeza has also submitted an application to the FDA requesting Orphan Drug designation. Gestiva is a long-acting, naturally occurring form of progesterone. If Gestiva is approved, Adeza will have the only commercially available, National Institutes of Health (NIH) studied, ACOG-recommended and FDA-approved therapeutic for...
Source: Medicine & Law Weekly (2006-06-02)
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