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MINNETONKA, Minn.--( BUSINESS WIRE )--Milla Pharmaceuticals Inc., a U.S. subsidiary of A.forall, announces the launch of generic Precedex® (dexmedetomidine hydrochloride injectable formulations of 200 μg per 50 mL and 400 μg per 100 mL in 0.9% sodium chloride solution in glass vials) by its partner Sagent Pharmaceuticals. Dexmedetomidine hydrochloride injection is indicated for sedation of patients who are initially intubated and mechanically ventilated during intensive care unit care.
Dexmedetomidine hydrochloride injection 200 mcg per 50 mL and 400 mcg per 100 mL is currently on the FDA drug shortage list. This latest version of Dexmedetomidine Hydrochloride Injection will help alleviate recent supply issues for this product in the United States.
The product is currently being launched after receiving what is called an "early round" ANDA (short for new drug application) approval, meaning it was approved in the first round of FDA review, which which was also the case for A.forall sodium acetate injection. 2 mEq/ml.
Dexmedetomidine Hydrochloride Injection is the fifth abbreviated drug application for A.forall that Milla Pharmaceuticals has filed in the U.S. market and the second successful Paragraph IV application. "While many other companies struggle to navigate the scientific and regulatory complexities of bringing one product, dexmedetomidine hydrochloride injection, to the U.S. market, our team was able to bring another product to American patients experiencing severe shortages. And that is exactly why we get up every morning - to bring high-quality, affordable medicines to patients in need, whether in the U.S., EU or around the world. We are just at the beginning of our journey to make affordable medicines available to all,” commented Philippe Van de Vliet, CEO of A.forall.
According to IQVIA®, annualized U.S. sales of dexmedetomidine hydrochloride for the 12 months ending May 2024 were approximately $117 million.
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