The company announced that the US Food and Drug Administration has accepted its NDA for FINTEPLA to treat seizures from Dravet syndrome.
Zogenix (NASDAQ:ZGNX) has announced that the US Food and Drug Administration (FDA) has accepted for filing its new drug application (NDA) for FINTEPLA to treat seizures associated with Dravet syndrome.
As quoted in the press release:
The FDA granted Priority Review for the NDA for FINTEPLA, which provides for a six-month review from the date of receipt, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2020.
“The FDA’s acceptance for filing of the NDA under Priority Review for our investigational product, FINTEPLA, represents a significant milestone in its development,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We are excited to continue working with the FDA with the goal of bringing FINTEPLA to Dravet syndrome patients and their families in need as quickly as possible.”
Priority review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
In its NDA filing acceptance letter, the FDA also stated that it is not currently planning to hold an advisory committee meeting to discuss the application for FINTEPLA.