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FDA steps up 2018 drug approvals by 11% on previous year

Published on 01/08/19 at 11:05am

The FDA continues to excel in the ground it covers as it emerges that the total number of new drug approvals awarded by the US regulator was up 11% in 2018 compared to the previous year, according to new GlobalData report.

The report, entitled ‘PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2019 Edition’, indicates that the regulator accepted 137 products throughout the year, beating the previous year’s 122 approvals. These included New Drug Approvals, Biologics License Applications, New Molecular Entities and new formulations of other drugs.   

It was also noted that this total came in 36% higher than the average of 101 approvals awarded by the organisation between 2012 and 2017.

This latest metric of success follows the administration’s record-breaking number of generic drug approvals in 2018, where 971 such products were authorised throughout the year.  

The report also noted an increase in novel drug approvals in Europe, with the EMA giving the green light to 89 products in total throughout 2018 – 48 new active substances (NAS), 14 non-NAS, and 16 biosimilar and 11 generic products, representing a 20% increase on the 2012-2017 average of 74.

Matt Fellows

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