The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 212571), manufactured by Mylan Laboratories Ltd.
The drug is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures, according to the FDA.
The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth, according to the FDA, and is included in the FDA’s Drug Shortage Database.
“The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public,” the agency said in an announcement.
