Dr Reddy’s Labs gets USFDA approval for generic Precedex

Dr Reddy's Labs gets USFDA approval for generic Precedex

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Medicine Injection Vaccine
Picture: Pixabay

Dr Reddy’s Laboratories Ltd. 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 (FDA).

“We are pleased to bring this important generic product to market, making it affordable-and readily available-for patients,” says Marc Kikuchi, chief executive officer, North America Generics, Dr. Reddy’s Laboratories. “Our ability to adequately supply dexmedetomidine is important for patients as it is on the FDA’s Drug shortage list.”

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The Precedex in 0.9% sodium chloride injection brand and generic market had U.S. 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.


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