Lenoir, NC September 11, 2019 – Exela Pharma Sciences is pleased to announce the launch of Sodium Bicarbonate Injection, USP. Exela received approval of its ANDA for Sodium Bicarbonate Injection in May for four separate presentations. The first presentation to launch will be the 8.4% Sodium Bicarbonate Injection, 50mEq/50mL (1mEq/mL) vials. This product has been on the FDA Drug Shortage list consistently and we are excited to be only the second FDA Approved Sodium Bicarbonate Injection on the US market. Exela will introduce shortly three additional presentations: an 8.4%, 10mEq/10mL (1mEq/mL) vial; a 7.5%, 44.6mEq/50mL (0.9mEq/mL) vial; and a 4.2%, 5mEq/10mL (0.5mEq/mL) vial.
Sodium Bicarbonate Injection is used for emergency care in hospitals to treat metabolic acidosis which may be due to severe kidney disease, cardiac arrest, uncontrolled diabetes and circulatory insufficiency due to shock or severe dehydration.
Exela also announces two significant partnerships that involve the distribution of Sodium Bicarbonate Injection, USP. First is the signing of an agreement with Premier to provide Exela’s Sodium Bicarbonate Injection through Premier’s ProvideGx program. ProvideGx provides Premier Members the opportunity to be guaranteed supply of drug shortage products during times when market conditions affect non-ProvideGx members. Exela is proud to have partnered with Premier and its ProvideGx membership on Sodium Bicarbonate Injection. The ProvideGx product will be marketed under the Exela label and is available in the market today. Please see Premier Press Release link here.
Second, we’d like to announce that Civica Rx has signed a long term agreement with Exela for the distribution of Exela’s Sodium Bicarbonate Injection through Civica to their 1000+ hospital members under the Civica label. Civica Rx was formed in 2018 as a non-profit organization with the mission to help find solutions to the chronic drug shortage problem in the US hospital market. Exela is very pleased to partner with them on Sodium Bicarbonate Injection. Distribution through Civica will begin in fourth quarter 2019. Please see Civica Rx Press Release here.
“We are thrilled to have this opportunity to work with Premier and Civica to ensure their member hospitals have sufficient supply of sodium bicarbonate,” said Phanesh Koneru, President and CEO of Exela Pharma Sciences. “Collaborating to alleviate drug shortages is an important way to achieve our mission of providing access to affordable medicines.”
