Gestiva Approval Unlikely In FY 09; KV Pharmaceutical Admits Credit Fumbles
This article was originally published in The Pink Sheet Daily
Firm halts manufacturing and distribution of nearly all products.
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Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.
Approval of the pre-term birth prevention therapy could pull KV Pharmaceutical back from the brink.