In 2014, FDA approved highest number of new drugs in 18 years

4 January 2015
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The US Food and Drug Administration's Center for Drug Evaluation and Research approved 41 novel medicines in 2014, 14 more than a year earlier, according to the agency’s website. That total is second only to the all-time high of 53 approvals reached in 1996.

The list of approvals included 15 drugs with orphan disease status, which are rare conditions and disorders that affect fewer than 200,000 people in the USA. Companies developing these compounds also benefit from seven years of competition-free marketing for each new orphan drug, as well as tax breaks on the costs of development. Nine drug approvals in 2014 benefited from the FDA's "breakthrough" designation, which speeds up the approval process.

The biggest beneficiary from the tally of FDA approvals was Anglo-Swedish firm AstraZeneca (LSE: AZN) with four, followed by the USA’s Biogen Idec (Nasdaq: BIIB), Eli Lilly (NYSE: LLY) and Merck & Co (NYSE: MRK) with three each.

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