15% of the 2013 FDA-approved new molecular entities are cold-chain products


Percentage is down from last year’s figure

FDA approved 27 new molecular entities (NMEs) in 2013, down from the 39 approved in 2012, which was a recent banner year. Of the 27, Pharmaceutical Commerce’s analysis shows that 4, or 15% of the total, are cold chain products, requiring storage and transportation at 2-8°C. Last year’s figure (which included some vaccines and blood products not included here) was 38%. HDMA’s Factbook, among other sources, indicates that around 10% of current industry stockkeeping units require refrigeration, so purely on that basis, 2013’s approvals show a continuing trend toward more cold-chain products coming from the industry.

Among cold chain products, all of the 2013 approvals had simply a 2-8° requirement on their labels—no frozen product or other temperature ranges. Of the 23 room-temperature products, there continues to be a non-standardization that some in the industry believe is an unnecessary complication for supply chain managers. Some list the storage temperature at 20°C; some at 25°, and one at “below 40°C”. Most give an excursion range of 15-30°C—but the variable there is the duration of the excursion.

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