FDA accepts LifeCycle Pharma's NDA for its fenofibrate drug candidate  

2006.12.22
The US Food and Drug Administration (FDA) has accepted LifeCycle Pharma's New Drug Application (NDA) for LCP-FenoChol, the company's most advanced product candidate
The US Food and Drug Administration (FDA) has accepted Danish biotech company LifeCycle Pharma's New Drug Application (NDA) for LCP-FenoChol, the company's most advanced product candidate, a fenofibrate for the treatment of abnormal lipid levels in the blood, including cholesterol and triglycerides. The FDA's acceptance indicates that the NDA is sufficiently complete to permit a substantive review of the data supporting LCP-FenoChol's safety and effectiveness, LifeCycle Pharma writes in a press release.
 
LifeCycle Pharma filed its application in October this year. Provided that the application is approved, the firm expects LCP-FenoChol can be launched in the first quarter of 2008. Flemming Ørnskov, CEO of LifeCycle Pharma comments: "LCP-FenoChol is our most advanced product candidate. Having made the decision to undertake full clinical development ourselves, we are proud to have met our first IPO milestone of obtaining acceptance of our filing of FenoChol with the FDA on time".
 
LifeCycle Pharma is based in Hørsholm north of Copenhagen. The company utilizes its proprietary Meltdose technology to improve the bioavailability of known and established compounds so that patients can absorb them more effectively. LifeCycle Pharma is listed on the OMX Nordic Exchange under the trading symbol (LCP). The news was reported by financial daily newspaper Børsen
 
Link > LifeCycle Pharma  

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