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US FDA extends Gestiva review for preterm birth

This article was originally published in Scrip

Executive Summary

The US FDAhas extended by three months its review of Hologic/KV Pharmaceutical's long-acting progesterone Gestiva to prevent preterm delivery. The new user fee date is January 25th. The NDA for Gestiva (17 alpha-hydroxyprogesterone caproate injection, or 17P) was initiated by Adeza Biomedical, which was acquired by Cytyc Corporation in April 2007. Later that year Hologic acquired the rights. In January, Hologic announced it sold the rights to KV upon approval of the pending NDA. In 2006 an FDA advisory panel recommended licensure for preventing preterm delivery, and the agency subsequently deemed Gestiva approvable pending an additional animal study and certain other conditions. If approved Gestiva would become the first FDA-licensed product for preventing preterm birth. A citizen's petition filed last year seeks to rescind the drug's orphan designation based upon 17P's longstanding availability and use in this indication.

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