Preterm Birth

U.S. FDA advisory committee to review Gestiva to prevent preterm births

Published in Medical Letter on the CDC and FDA, August 20th, 2006

Adeza (ADZA) announced that its New Drug Application (NDA) for Gestiva will be reviewed by the Reproductive Health Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA).

Gestiva, a long acting form of a naturally occurring progesterone, is the company's drug candidate to prevent preterm birth in women with a history of preterm delivery.

"The setting of an advisory committee meeting date marks an important next step in the Gestiva NDA review process," said Emory V. Anderson, president and chief executive officer. "A preterm birth occurs nearly every minute and imposes a $26 billion annual cost to the U.S. healthcare system. For the...

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Source: Medical Letter on the CDC and FDA (2006-08-20)

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