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Innovus Pharmaceuticals, Inc. announced that its partner Khandelwal Laboratories received the approval of the product licenses for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® from the Indian FDA, The Drugs Controller General (India), and the Directorate General of Health Services to commercialize the products in India.
"We are thrilled to have received the approval to commercialize our products from the Indian FDA in a very short time due to the strength of the dossier and the clinical trials.India is our seventh country where we have our products approved and we look forward to start the commercial launch by our partner Khandelwal Labs in the very near future," said Dr. Bassam Damaj, President and CEO of Innovus Pharmaceuticals, Inc.
On September 10, 2015 Innovus Pharma entered into an exclusive marketing and distribution agreement with Khandelwal Laboratories based in India ("KLab") under which Innovus Pharma has granted to KLab an exclusive ten-year license and distribution rights to market and sell Innovus Pharma's products. These products include Zestra® to increase Female Sexual Arousal and Desire and Satisfaction, EjectDelay® for treating premature ejaculation, Sensum+® to increase penile sensitivity and Zestra Glide®, the high-viscosity water-based lubricant. If KLabs exceeds its minimum yearly orders, the agreement has two five-year term extensions. Under the agreement, the minimum orders for the first term of the agreement are over two million and six hundred thousand ($2.6M) US dollars annually.
Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in 276 women to increase in a statistical significant manner the arousal, desire and sexual satisfaction in FSI/AD women. Zestra® is the first Natural Health Product (NHP) to receive approval for the indication of FSI/AD in Canada as an NHP. To date, the Company believes that no product has been approved to treat FSI/AD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. Zestra® is currently available in the United States, Canada and Morocco.
