Biotech Values

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NCE: In shift, FDA to give 5-year exclusivity for fixed dose combination (FDC) containing a new active moiety

[It confirmed my previous contention that FDA was trying to make general guidance on this subject by delaying exclusivity decision on AMRN's Vascepa and GILD's Stribild]

New Interpretation

"As a result, an application for a fixed-combination submitted under section 505(b) of the FD&C Act will be eligible for 5-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b).30," FDA explained. "For example, a fixed-combination drug product that contains a drug substance with a single, new active moiety would be eligible for 5-year NCE exclusivity, even if the fixed-combination also contains a drug substance with a previously approved active moiety."

http://www.raps.org/focus-online/news/news-article-view/article/4680/utm_source/social/utm_medium/post/utm_campaign/rfnews.aspx

Here is draft guidance which will apply from now on, not retroactively to already approved, ie GILD's Stribild and Bayer's Natazia:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf