September 12, 2014 San Diego, CA
Jaleva’s Mastisol Plus Bacitracin product receives exemption from the FDA.
The FDA issued a letter to Jaleva Pharmaceuticals giving the green light to the company to commercialize the post-operative product. “This is a significant milestone as exemption has now cleared the way for this product to be sold to hospitals and surgical centers throughout the U.S.,” said Eva Beim, CMO of Jaleva.
“When we knew the product was considered a Class 1 device, according to the top FDA Advisors in the country, we knew this was a win for the company,” Alex Battaglia, CSO of Jaleva stated.
The product is a 2-for-1surgical post-op product which is placed around the wound prior to applying a bandage. It addresses the growing need for further protection of patients in the effort to help prevent infection.