FDA approves AstraZeneca type 2 diabetes drug
Jan 8 (Reuters) - U.S. health regulators on Wednesday approved an AstraZeneca drug from a new class of medicines to treat type 2 diabetes after previously rejecting it over safety concerns.
The Food and Drug Administration nod had been expected this time around after an outside advisory panel of experts in December voted by a wide margin to recommend its approval, saying the benefits of the drug, dapagliflozin, outweighed its safety risks. It will be sold in the United States under the brand name Farxiga.
The medicine was co-developed by Bristol-Myers Squibb Co and AstraZeneca, but Astra late last year bought out Bristol's stake in their diabetes joint venture for more than $4 billion, including upfront and sales-related milestone payments.