Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, which is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. The drug should be administered by continuous infusion not to exceed 24 hours. 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. The new approval will help reduce recent supply issues experienced in the U.S. as Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL is currently on FDA’s Drug Shortages list. Filip Van de Vliet, CEO of the Alter Pharma Group commented that this new approval makes them extremely proud as only between 12% and 15% of all ANDAs filed get a First Cycle Approval.
Keywords: Milla Pharmaceuticals Inc., Alter Pharma Group, FDA approval, generic version, Dex