FDA approves generic dexmedetomidine hydrochloride injection for ICU patients

The FDA has approved two sizes of dexmedetomidine hydrochloride injection for sedation purposes in ICU patients who are intubated or on mechanical ventilation, according to a press release from Milla Pharmaceuticals Inc.

The newly approved dexmedetomidine hydrochloride injection 4 µg/mL (Milla Pharmaceuticals Inc.) is a generic version of Precedex and is to be given through continuous infusion that should end before the 24-hour mark, according to the release.

With this approval of the injection in 50 mL and 100 mL, both of which are on the FDA’s Drug Shortage List, the release said this action will play a role in combatting supply issues.

“This new Alter Pharma [abbreviated new drug application (ANDA)] approval, which is the fifth already over a period of less than 3 years, [including] two after a first cycle review, makes us extremely proud,” Filip Van de Vliet, CEO of Alter Pharma Group, of which Milla Pharmaceuticals Inc. is a subsidiary, said in the release. “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.”