FDA extends review of Novo Nordisk's Degludec by 3 mths
COPENHAGEN, June 8
COPENHAGEN, June 8 (Reuters) - Danish drugmaker Novo Nordisk , the world's biggest insulin maker, said on Friday that U.S. health regulators have extended their review of ultra-long-acting insulin products Degludec and DegludecPlus by three months to consider further data.
A decision on the review of the drug candidates to treat type 1 and type 2 diabetes is now expected on Oct. 29.
The U.S. Food and Drug Administration asked for further data clarification and analyses, and the company has submitted a substantial amount of additional data.
"Due to the size and timing of these submissions the FDA considers them as major amendments to the (new drug applications)," the company said in a statement, adding that the agency had not requested additional clinical trials.
Novo Nordisk has also filed for approval of the two products with the European Medicines Agency and regulators in Japan, Canada, Switzerland and some other countries, it said.
It first filed for approval with the FDA in Sept. 2011.
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