Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Dexmedetomidine Hydrochloride Injection, which is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. The drug will be available in 50mL and 100mL and will help reduce recent supply issues experienced in the U.S. This marks the second “First Cycle” Approval ANDA for Milla Pharmaceuticals Inc. and the Alter Pharma Group for the U.S. market after their first “First Cycle” Approval ANDA for Sodium Acetate Injection 2MEQ/mL in the Summer of 2021, which was also an FDA Drug Shortage listed product. The approval highlights the expertise of scientific and regulatory teams that helped achieve this milestone.
Keywords: Milla Pharmaceuticals Inc., Alter Pharma Group, FDA approval, Dexmedetomidine Hydrochloride Injection, sedation
Milla Pharmaceuticals has announced that it has received FDA approval for its generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL. It plans to launch soon to help reduce recent supply issues experienced in the US due