KV Pharmaceutical: FDA Issues New Update On Makena
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Sunday, Aug 52012, 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) |Sunday, Aug 52012, 5:46 AM| Comment!
Friday, Jul 62012, 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. |Friday, Jul 62012, 11:46 AM| 1 Comment
Monday, Jun 182012, 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. |Monday, Jun 182012, 9:57 AM| Comment!
Monday, Jan 232012, 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. |Monday, Jan 232012, 8:17 AM| Comment!
Friday, Jan 202012, 3:17 PMShares of K-V Pharmaceutcial (KV.A +10.4%) rally as rival Columbia Laboratories (CBRX) gets raked over the coals by the FDA in a review of its preterm birth gel that ends up concluding the firm's data isn't sufficient. (previous: I, II). Trading on CBRX still halted. |Friday, Jan 202012, 3:17 PM| Comment!
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