Long Grove Pharmaceuticals announced the strategic in-licensing of norepinephrine in 0.9% sodium chloride premix formulation from Nevakar Injectables, Inc. This manufactured, ready-to-use formulation is room temperature-stable and will be available in three commonly administered strengths: 4 mg/250 mL (16 mcg/mL), 8 mg/250 mL (32 mcg/mL) and 16 mg/250 mL (64 mcg/mL). The new option is intended to help strengthen what has historically been a fragile critical care supply chain.
Norepinephrine bitartrate in 0.9% sodium chloride injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. It is one of the most commonly used injectable medications in the critical care setting. Nevakar Injectables, Inc. received FDA clearance for norepinephrine bitartrate in 0.9% sodium chloride injection as a 505(b)(2) NDA in October 2022.
"Our partnership with Nevakar is aimed at helping increase the reliability related to this essential critical care product," said Peter Karas, the chief commercial officer of Long Grove Pharmaceuticals. "Norepinephrine premix has the potential to enhance patient safety as well as our customers' operational efficiencies by eliminating the potential risks and complications associated with compounding."
“Nevakar has a long commitment to creating new formulations from existing molecules with the potential to improve the quality of care,” said Sriram Ramanathan, the CEO of Nevakar Injectables, Inc.