Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Yet Another “First Cycle” FDA Approval for an Abbreviated New Drug Application (ANDA), Dexmedetomidine Hydrochloride Injection

MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it 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.

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 U.S.

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

“This new Alter Pharma ANDA approval, which is the 5^th already over a period of less than three years, out of which 2 after a first cycle review, makes us extremely proud,” commented Filip Van de Vliet, CEO of the Alter Pharma Group. “In fact, on average only between 12% and 15% of all ANDAs filed get a First Cycle Approval, meaning the FDA did not identify any shortfalls or deficiencies during the first cycle review hence no additional requests are being asked. The fact that our two most recent filings both got a First Cycle Approval can only be explained by the extremely high expertise of our scientific and regulatory teams.”

About Milla Pharmaceuticals Inc.

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 U.S. market focused on niche injectable and solution products for hospitals and clinics.

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