Acrux History

ACRUX TIMELINE

2023

As at August 2023, Acrux has six approved products with 3 ANDA's under review by the FDA.

2023

Positive FDA Remote Regulatory Assessment (RAA)
FDA concluded - “we did not identify objectionable conditions and thus do not have any observations…”

2022

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.

2022

Acrux has had 6 ANDAs accepted for review by the FDA.

2020

Development agreement with commercial organisations for marketing of the Acrux developed ANDA products in the United States.

2019

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.

2018

Submitted first two ANDA (generic) products to the FDA for review

2017

Active pipeline of 10 generic ANDA products.

2016

Lenzetto® launched in Europe by our licensee Gedeon Richter.

2014

Evamist® licensed to Perrigo in US

2011

Axiron® launched by Eli Lilly

2010

Acrux submits Axiron® NDA to FDA

2008

Evamist® launched by KV Pharmaceutical

2007

Evamist® licensed to KV Pharmaceutical in US

2004

Acrux listed on ASX (ACR:ASX)

2003

Veterinary licensed to Elanco globally (including Recuvyra®)

2001

First US patent granted

1998

Acrux incorporated