Nevakar Injectables Receives U.S. FDA Approval of Ready-to-Use Ephedrine Injection in a Prefilled Syringe
BRIDGEWATER, NJ – April 28, 2022 – Nevakar Injectables Inc. (“Nevakar”), a wholly owned subsidiary of Nevakar, Inc., is a biopharmaceutical company developing multiple sterile injectable products for use in the critical and ambulatory care settings, and announced today that the U.S. Food and Drug Administration (“FDA”) has approved its ready-to-use Ephedrine Sulfate Injection (“Ephedrine”) in a prefilled syringe (“PFS”). This product is an ephedrine formulation prediluted to a 5mg/mL concentration and supplied in a ready-to use 5mL PFS. It will be marketed and sold in the U.S. by the Par Sterile Products (“Par”) business of Endo International plc (“Endo”) (NASDAQ: ENDP). Ephedrine is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery.
Last month, Nevakar announced the launch of its ready-to-use ephedrine prediluted vial. With the added approval of the ephedrine prefilled syringe, Nevakar and Endo aim to offer a portfolio of ephedrine products to health care professionals treating patients in the surgical setting.
Investor Contacts for Nevakar:
Chief Financial Officer
T: (908) 699-4940
E: [email protected]
Lisa M. Wilson
In-Site Communications, Inc.
T: (212) 452-2793
E: [email protected]
About Nevakar Injectables, Inc.
Nevakar Injectables, Inc. is a wholly owned subsidiary of Nevakar, Inc., a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Nevakar Injectables is developing a broad portfolio of injectable products for use in the hospital and ambulatory care settings. The Company has active programs in critical patient care, acute pain management, long acting injectables, and hospital injectables. For additional information please visit www.nevakarinjectables.com.
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
About Par Pharmaceutical
Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and other differentiated products. Par Pharmaceutical is an Endo company. Learn more at www.parpharm.com.