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US FDA new drug approvals hit 16-year high in 2012

Published on Jan 1, 2013 8:30 AM

LONDON/NEW YORK (REUTERS) - United States (US) regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years to generic drug makers because of patent expirations.

There were eight approvals in December alone, including a new treatment from Johnson & Johnson called Sirturo for drug-resistant tuberculosis approved on Monday, the first new TB drug in decades.

The pharmaceutical sector badly needs a pick-up in productivity as companies try to refill their medicine chests after heavy losses to generic manufacturers, which have benefited from a string of patent expirations that peaked in 2012. When generics go on the market at a lower cost, sales of name brand drugs plummet.

The tally of 39 new drugs and biological products approved by the Food and Drug Administration (FDA) compares with 30 in 2011 and just 21 in 2010. At least 10 of the drugs had fast track status in 2012, which enabled them to be reviewed more quickly.

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