Milla Pharmaceuticals, Alter Pharma Group Announce Another "First Cycle" FDA Approval for an Abbreviated New Drug Application, Dexmedetomidine Hydrochloride Injection
12 June 2023 - - US-based Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Precedex, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, and plans to launch in the very near future, the company said.

Dexmedetomidine Hydrochloride Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.

It should be administered by continuous infusion not to exceed 24 hours.

Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL is currently on FDA's Drug Shortages list. 

This latest approval of Dexmedetomidine Hydrochloride Injection will help reduce the recent supply issues for the product experienced in the US.

This achievement marks the second "First Cycle" Approval ANDA for Milla Pharmaceuticals Inc. and the Alter Pharma Group for the US 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.

This new milestone also marks the approval of our second Paragraph IV Filing and the 5th ANDA approval for the Alter Pharma Group.

Milla Pharmaceuticals Inc., a wholly-owned subsidiary of the Alter Pharma Group, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the US market focused on niche injectable and solution products for hospitals and clinics.