FDA approves Milla Pharmaceuticals’ generic version of Precedex

The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL.

The injection is indicated for the sedation of initially intubated and mechanically ventilated patients receiving treatment in an intensive care setting.

It is given by continuous infusion not exceeding 24 hours’ duration.

Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list.

It noted that the injection’s latest approval will help reduce the recent supply issues for the product in the country.

This latest move marks Milla Pharmaceuticals’ second ‘first cycle’ FDA approval for an abbreviated new drug application (ANDA) and second paragraph IV filing.

The first approval is for sodium acetate injection 2MEQ/mL, granted in 2021.

The sodium acetate injection 2MEQ/mL was also an FDA drug shortage listed product.

Milla Pharmaceuticals’ parent company Alter Pharma Group CEO Filip Van de Vliet stated: “This new Alter Pharma ANDA approval, which is the fifth already over a period of under three years, out of which two were after a first cycle review, makes us extremely proud.

“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.”