It took Evoke Pharma two years and a couple rounds of fundraising to slice and pull the data for an NDA of its only drug out of a Phase III wreckage. But just a month before the FDA was slated to give its verdict, the biotech reported that the effort might not have been enough after all.
Dave Gonyer
The agency has seen deficiencies during the initial stage of its review, Evoke said on Monday, in three critical sections of the NDA. Although the comments outlined in the multi-disciplinary review are preliminary, the company conceded that ?approval of Gimoti by the PDUFA date of April 1, 2019 is uncertain given the letter.?
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Adamis’ erectile dysfunction treatment hits regulatory snag as FDA calls marketing application incomplete
San Diego-based Adamis has stumbled in its attempt to get a lower-cost erectile dysfunction drug on the market.
The specialty pharmaceutical company ? which focuses on developing cheaper drugs for various disorders ? said the FDA had deemed its marketi… […]
