Dr Reddy’s launches dexmedetomidine hydrochloride in 0.9% sodium chloride injection in US

Dr Reddy’s Laboratories announced the launch of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, a therapeutic equivalent generic version of Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection, approved by the US Food and Drug Administration (USFDA).

It is a relatively selective alpha-adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. It is also used for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Marc Kikuchi, CEO, North America Generics, Dr Reddy’s Laboratories said, “Our ability to adequately supply Dexmedetomidine is important for patients as it is on the FDA’s Drug Shortage list.”

The Precedex in 0.9% Sodium Chloride Injection brand and the generic market had US sales of approximately $210 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr Reddy’s Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL clear glass vials, respectively. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only.