FDA fast tracks AbbVie hepatitis C drug

May 6, 2013 2:24 PM

33 0

AbbVie said Monday that its new hepatitis C drug regimen has been given a breakthrough therapy designation by the Food and Drug Administration, putting it on the fast track for potential approval in the United States.

A breakthrough therapy designation from the FDA is intended to expedite the development and review of drugs for serious or life-threatening conditions. It requires preliminary clinical proof that shows the drug may provide "substantial improvement" over therapies currently on the market.

Read more

To category page