As at August 2023, Acrux has six approved products with 3 ANDA's under review by the FDA.
Positive FDA Remote Regulatory Assessment (RAA)
FDA concluded - “we did not identify objectionable conditions and thus do not have any observations…”
AB-rated generic version of Emla® Cream (Lidocaine 2.5% and Prilocaine 2.5% Cream) launched in USA Dec 2022 by our Acrux licensee, Padagis.
Acrux has had 6 ANDAs accepted for review by the FDA.
Development agreement with commercial organisations for marketing of the Acrux developed ANDA products in the United States.
Submitted third ANDA (generic) product to the FDA for review.
Lenzetto® marketed in over 30 countries in Europe and other countries outside Europe.
Active pipeline of 14 generic products.
Submitted first two ANDA (generic) products to the FDA for review
Active pipeline of 10 generic ANDA products.
Lenzetto® launched in Europe by our licensee Gedeon Richter.
Evamist® licensed to Perrigo in US
Axiron® launched by Eli Lilly
Acrux submits Axiron® NDA to FDA
Evamist® launched by KV Pharmaceutical
Evamist® licensed to KV Pharmaceutical in US
Acrux listed on ASX (ACR:ASX)
Veterinary licensed to Elanco globally (including Recuvyra®)
First US patent granted