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K-V Pharma's Gestiva delayed again

The US Food and Drug Administration has again pushed back its decision on Gestiva for the prevention of preterm birth

The US Food and Drug Administration (FDA) has once again pushed back its decision on Gestiva (hydroxyprogesterone caproate injection), a drug for the prevention of preterm birth that was submitted to the agency by Hologic Inc. but will be licensed and sold by K-V Pharmaceutical if it is approved.

In July of last year, Hologic resubmitted the new drug application for Gestiva in response to concerns about the original submission raised by the FDA in a 2009 complete response letter. Following the July resubmission, the FDA assigned an action date on the application of January 13, 2011. However, the agency recently made another request for additional information, which was provided by Hologic on January 10.

In order to allow time to review the new information, the FDA has pushed back the action date for the drug once again, now setting it for April 13, 2011.

"Based on the information provided, the company remains confident in the approval of Gestiva and believes a positive action by the FDA is likely on or before the new Prescription Drug User Fee Act (PDUFA) date," K-V said in a statement.

However, the delay comes at a difficult time for the company, which has been plagued by financial troubles after being forced to pull some approved women's health products off the market due to manufacturing difficulties. K-V said it is "further evaluating its liquidity outlook" in light of the latest delay.

K-V recently announced that it would focus on the development and commercialisation of branded specialty pharmaceuticals going forward, a strategy based in part on the expectation of Gestiva's near-term approval. If Gestiva is eventually approved, it will be the first and only marketed drug 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.

12th January 2011

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