ACRUX TIMELINE
![](https://www.acrux.com.au/wp-content/uploads/2021/12/Screenshot_20211210-115441_Samsung-Internet-02-400x180.jpeg)
As at August 2023, Acrux has six approved products with 3 ANDA's under review by the FDA.
![](https://www.acrux.com.au/wp-content/uploads/2023/02/FDA.png)
Positive FDA Remote Regulatory Assessment (RAA)
FDA concluded - “we did not identify objectionable conditions and thus do not have any observations…”
![](https://www.acrux.com.au/wp-content/uploads/2023/02/New-Product-launched-260x180.png)
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.
![](https://www.acrux.com.au/wp-content/uploads/2022/09/Submitted_Red-1-400x180.jpg)
Acrux has had 6 ANDAs accepted for review by the FDA.
![](https://www.acrux.com.au/wp-content/uploads/2021/12/Picture1-363x180.jpg)
Development agreement with commercial organisations for marketing of the Acrux developed ANDA products in the United States.
![](https://www.acrux.com.au/wp-content/uploads/2019/09/submitted-stamp2.png)
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.
![](https://www.acrux.com.au/wp-content/uploads/2019/02/submitted-stamp.png)
Submitted first two ANDA (generic) products to the FDA for review
![](https://www.acrux.com.au/wp-content/uploads/2018/03/2017-400x180.jpg)
Active pipeline of 10 generic ANDA products.
![](https://www.acrux.com.au/wp-content/uploads/2014/03/lenzetto-product-box-480x180.jpg)
Lenzetto® launched in Europe by our licensee Gedeon Richter.
![](https://www.acrux.com.au/wp-content/uploads/2014/03/20141.jpg)
Evamist® licensed to Perrigo in US
![](https://www.acrux.com.au/wp-content/uploads/2014/03/2011.jpg)
Axiron® launched by Eli Lilly
![](https://www.acrux.com.au/wp-content/uploads/2014/03/20101.jpg)
Acrux submits Axiron® NDA to FDA
![](https://www.acrux.com.au/wp-content/uploads/2014/03/20081.jpg)
Evamist® launched by KV Pharmaceutical
![](https://www.acrux.com.au/wp-content/uploads/2014/03/20071.jpg)
Evamist® licensed to KV Pharmaceutical in US
![](https://www.acrux.com.au/wp-content/uploads/2014/03/2004.jpg)
Acrux listed on ASX (ACR:ASX)
![](https://www.acrux.com.au/wp-content/uploads/2014/03/20031.jpg)
Veterinary licensed to Elanco globally (including Recuvyra®)
![](https://www.acrux.com.au/wp-content/uploads/2014/03/2001.jpg)
First US patent granted
![](https://www.acrux.com.au/wp-content/uploads/2019/03/Timeline-1.jpg)
Acrux incorporated