Nevakar Injectables Receives U.S. FDA Approval of Ready-to-Use Ephedrine Injection in a Prefilled Syringe
April 28 2022 - 6:30AM
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.
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.
About EndoEndo (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 PharmaceuticalPar 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.
Investor Contacts for Nevakar:
Marshall WoodworthChief Financial Officer(908) 699-4940E:
mwoodworth@nevakar.com
Lisa M. WilsonIn-Site Communications, Inc. T: (212) 452-2793E:
lwilson@insitecony.com
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