Vivus has received NDA approval for TA-1790 (avanafil), indicated for the treatment of erectile dysfunction (ED), in the US.
VIvus will market the product under the brand name Stendra in the US.
Mitsubishi Tanabe Pharma has discovered TA-1790 as ED therapy, which is expected to have an immediate onset with lesser side effects.
In February 2011, Mitsubishi licensed the development and marketing rights of the product to Vivus, excluding Japan and certican Asian countries.
Vivus has filed MAA for TA-1790 in the Europe. The product has gained approval in South Korea and has been commercialized by JW Pharma under the brand name Zepeed from October 2011.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/vivus-wins-nda-approval-for-erectile-dysfunction-therapy-in-us-080512