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FDA Approves PDUFA Fee Waiver for Gimoti™ New Drug Application
Mar. 05, 2018 08:59AM PST
Pharmaceutical InvestingEvoke Pharma (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million for the 505(b)(2) New Drug Application (NDA) for Evoke’s Gimoti, nasal …
Evoke Pharma (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million for the 505(b)(2) New Drug Application (NDA) for Evoke’s Gimoti, nasal delivery formulation of metoclopramide for the treatment of symptoms associated with gastroparesis in women. The Company remains on track to file the Gimoti NDA next quarter.
As quoted in the press release:
“FDA’s grant of the PDUFA fee waiver enables us to continue to focus our resources on finalizing the Gimoti NDA filing. As we review our 2018 budget, we are able to extend our cash runway into October 2018. We continue to remain conservative with our expenditures and with a projected NDA filing next quarter, we look forward to a potential U.S. product launch in 2019,” commented Dave Gonyer, President and CEO.
