Colin Kellaher. By
Fenek Pharmaceuticals Inc. on Monday said it expects the US Food and Drug Administration to once again reject the company’s application for the trademark because of problems with the plant where the drug is made.
The Durham, NC, specialty pharmaceutical company said it expected to receive an FDA full response letter indicating that the agency would not approve the application in its current form, now that the target action date of November 27 for the application has passed. .
Fenec is seeking Pedmark’s approval for intravenous administration for the prevention of hearing loss associated with cisplatin chemotherapy in children.
The FDA turned down Fenac’s application last year after discovering deficiencies during a pre-approval inspection of the company’s drug-product maker’s facility. Fennec resubmitted its application earlier this year, and the FDA accepted it with a June 27 target action date.
Fennec said on Monday that the FDA has again found deficiencies in its drug-product manufacturer> Once it has received an official disapproval, Fenek will meet with the agency to discuss the steps needed to resubmit the Pedmark application. will request to do so, the company said.
Shares of Fennec, which closed Friday at $9.64, fell 33% to $6.44 in premarket trading on Monday.
Write to Colin Kellaher at [email protected]