FDA declines approval of AstraZeneca diabetes drug combination
LONDON – US health regulators declined to approve AstraZeneca’s fixed-dose combination of the diabetes drugs saxagliptin and dapagliflozin, dealing a blow to an important plank of the drugmaker’s business.
AstraZeneca said on Friday it had received a so-called complete response letter from the Food and Drug Administration stating that more clinical data were required. Such letters typically outline concerns and conditions that must be addressed in order to gain U.S. approval. -Reuters