Currently, Zestra is approved and marketed in Canada for the indication of ‘Temporary Increase of Desire in Female Sexual Desire Disorder Women (FSDD)’.
The company said that the review process for the new label indication is 120 days from filing.
FSI/AD is a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity.
The company said that diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress.
Zestra is the only over the counter (OTC) natural product clinically proven in two US double-blind, placebo controlled trials carried out in 276 women to increase arousal, desire and reduce pain during sexual intercourse.
The drug is commercialized in the US and Canada and has sold millions of units since its launch in 2007.
Innovus Pharmaceuticals president and chief executive officer Bassam Damaj said the expanded label if approved will make Zestra the only product approved and marketed in Canada for FSI/AD and will make the product the first-to-market for this large therapeutic indication.
"Our efforts to commercialize the products in additional markets such as Europe are moving forward as the Company is preparing for scientific guidance from the European Medicine Agency for the regulatory status path of the product in Europe," Damaj said.