Astra drug to face FDA delay

ASTRAZENECA’S potential new blockbuster heart drug Brilinta faces a three-month delay in winning approval in the United States, slicing valuable revenue-earning time off the product.

The company said the Food and Drug Administration (FDA) needed more time to study the application and would now complete its review by 16 December rather than by 16 September as originally indicated.


Brilinta is AstraZeneca’s most important pipeline product and the company is relying on its revenues to offset expiring patents.