H.I.G. Capital News
Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials
BRIDGEWATER, NJ - October 22, 2020 – Nevakar Inc., a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready- to-use 50mg/10 ml single use vial presentation. Under an exclusive licensing agreement with Endo International’s (NASDAQ: ENDP) subsidiary, Endo Ventures Limited, Par Pharmaceuticals’ Sterile Products division will launch and distribute the product. This is the first approval under the previously announced collaboration between Nevakar and Endo for the development of five differentiated, sterile injectable products in the U.S. and Canada. Under the terms of the agreement, Nevakar has responsibility to develop and obtain FDA approval for these products and Par Pharmaceuticals’ Sterile Products division will launch and distribute the products.
“We are pleased to have received approval for this convenient, patent pending, ready-to-use form of a frequently used treatment for clinically important hypotension during anesthesia. We value our strong partnership with Endo, a respected pharmaceutical company with a significant and growing presence in sterile and critical care products as we pursue our mission to develop innovative pharmaceutical products that improve patient care and quality of life,” stated Navneet Puri, Ph.D., Founder, Chairman and Chief Executive Officer of Nevakar.
About Nevakar Inc.
Nevakar Inc. is growing as a fully integrated biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patient care and quality of life. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.
Marshall Woodworth Chief Financial Officer (908) 625-3547
Lisa M. Wilson (212) 452-2793