(ChatterShmatter) – Drug maker AstraZeneca have received a full response letter from the Food and Drug Administration pertaining to their experimental heart drug called Brilinta.
The company was hoping for a quick favorable response from the FDA, but in their letter the agency requested more information on Brilinta, delaying their decision whether or not to approve it or not.
Brilinta is already approved for use by the European Medicines Agency, and AstraZeneca is banking on its approval in the US as certain pateants on their current drugs are set to expire.
The response letter asks for additional information on Brilinta, but luckily for the drug maker it does not ask for additional studies to be performed.
News of the response letter was quick to impact shares of AstraZeneca which fell by more than 5 percent.