Belviq, sobre la aprobación o no aprobación como NCE
http://seekingalpha.com/article/1252611-amarin-s-descent-to-5?source=email_rt_article_title
According to the FDA, "new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted." In the context of this definition, the FDA is comparing Vacepa to GSK's (GSK) Lovazza. The FDA is likely saying that Vacepa and Lovazza are effectively the same. They have the same active ingredients - a prescription-grade omega-3 fatty acid, comprising of ultra pure EPA (icosapent ethyl). It just happens that Amarin's version is purer than GSK's.
Although the three versus five year NCE debate may sound trivial, it has a significant impact beyond the two year difference. Per FDA rules if a pharma/biotech is awarded a five year NCE, then no other company can submit an application to gain market approval for a similar drug until the fourth year of that NCE
«Después de nada, o después de todo/ supe que todo no era más que nada.»