Gestiva

[diana.papshev]

Anonymous member request:
"I would like to see an update on the projected availability for Gestiva"

[chantell.reagan]

Gestiva (17-alpha hydroxyprogesterone caproate) is an IM injection for prevention of preterm labor, that is still in late-phase development. Of note:

*In 1/2009, the FDA rejected Gestiva NDA requesting that a portion of the patient population in a phase IIIb/IV study be enrolled before approval can be granted – It’s not clear how long this is going to take, since KV pharmaceutical (and Hologic) did not release the specifics.
* In 1/2010, KV updated their agreement with Hologic purchasing full rights to Gestiva. However, KV CEO stated that the company’s first priority is to get their approved products back on the market.
*Bottom line: we are estimating the FDA review to happen by 4Q2010

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