Record number of FDA new drug approvals in 2012 for 16 years

Hannah Blake


The US Food and Drug Administration approved the highest number of new drugs in 2012 than it has done since 1996, 16 years ago. The regulatory body approved 39 new drugs in 2012 – eight of these approvals were in December alone, including Sirturo for drug-resistant tuberculosis, developed by Johnson &amp, Johnson, which is the first new tuberculosis drug to be approved in four decades.

2012’s 39 new drug approvals compares with 30 approvals in 2011 and only 21 in 2012. At least 10 of the approved drugs were given fast track status, allowing them to be reviewed more quickly. This is the highest amount of new drugs and biological products approvals since 1996 when 53 new drugs were approved.

In recent years, pharmaceutical companies have lost millions of pounds following the increase in generic competition as top drugs’ patents expired. This boost of new drug approvals shows that the industry is back on track and poised for further growth in this New Year.




Related news:

Drug Approvals Reach 15-Year High on Smoother FDA Reviews (Bloomberg)

FDA new drug approvals hit 16-year high in 2012 (Reuters)

J&amp,J Tuberculosis Drug Gets Fast-Track Clearance (Wall Street Journal)

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