11:52 AM
Jan 17, 2019
 |  BioCentury  |  Regulation

Products on shutdown standby

Products on shutdown standby

On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products in that time. At least 10 other new products and three label expansions for marketed products have PDUFA dates in 1Q19 after the reserve funding runs dry. Five of those applications are under Priority Review; among them is the March 1 deadline for siponimod from Novartis AG (NYSE:NVS; SIX:NOVN) to treat secondary progressive multiple sclerosis. Novartis AG (NYSE:NVS; SIX:NOVN) paid Ultragenyx...

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