KV Pharmaceutical: FDA Issues New Update On Makena
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Aug. 5, 2012, 5:46 AMK-V Pharmaceutical (KV.A) filed for bankruptcy protection yesterday, citing the FDA's failure to enforce orphan drug marketing exclusivity for the Missouri firm's Makena drug for helping prevent premature births. This included enabling some state Medicaid agencies to limit access to the treatment. K-V also blamed manufacturing and marketing restrictions on some of its other products. (PR) | Comment!
Jul. 6, 2012, 11:46 AMK-V Pharmaceutical (KV.A -16.8%) tanks after saying it's filed a lawsuit against the FDA for failing to crack down on compounded versions of its premature birth drug Makena. Pharmacies have been using the active ingredient hydroxyprogesterone, which does not have a formal FDA clearance, to compound cheaper versions of Makena, an injectable hormonal medicine that reduces the risk of pre-term birth in pregnant women with a history of early deliveries. | 1 Comment
Jun. 18, 2012, 9:57 AMThe FDA says its analysis of compounded versions of the active ingredient in K-V Pharmaceuticals’ (KV.A -16.2%) Makena premature-birth prevention drug did not identify any major safety problems, but the agency reiterates that approved drugs are generally safer and more effective than compounded products. | Comment!
Jan. 23, 2012, 8:17 AMColumbia Labs (CBRX) -52.5% premarket after trading was suspended all day Friday following the FDA's negative vote on the company's Prochieve drug candidate. Partner Watson Pharmaceutials (WPI) is little changed after falling 3.5% on Friday. Rival K-V (KV.A) +1.9% after Friday's 9.3% gain. | Comment!
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