Milla Pharmaceuticals obtains FDA OK for generic Precedex

Milla Pharmaceuticals has received the Food and Drug Administration’s blessing for generic Precedex (dexmedetomidine hydrochloride injection) 4 mcg/ml in 50 ml and 100 ml.

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

The medication is given by continuous infusion not exceeding 24 hours duration.

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Precedex is on the FDA’s drug shortages list, the company said, noting 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.

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“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,” said Filip Van de Vliet, CEO of Milla’s parent company 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.”