MediWound receives FDA approval of NexoBrid for treatment of severe burns

In a BLA approval letter posted the site of the FDA that was sent to MediWound, the Agency stated: "We are issuing Department of Health and Human Services U.S. License No. 2215 to MediWound, Ltd, Yavne, Israel, under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards. Under this license, you are authorized to manufacture the product NexoBrid (anacaulase-bcdb) gel which is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns." Reference Link