Posted by Michael Wonder on 02 Aug 2018
Acrux submits first-to-file application for generic version of Jublia making it eligible for 180 days of generic exclusivity
2 August 2018 - Acrux is pleased to announce that the US FDA has accepted for review the Paragraph IV Abbreviated new drug application dossier submitted by Acrux for its generic version of Jublia (efinaconazole) topical solution, 10%.
The FDA has confirmed the submission date for Acrux’s Efinaconazole Topical Solution 10% ANDA, which corresponds to the first date on which an ANDA could be lawfully submitted.
Based on available information, Acrux believes it is one of the first companies to have submitted an ANDA containing a Paragraph IV Certification for this product and expects to be eligible for 180 days of generic marketing exclusivity upon final FDA approval.
