From USFDA
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride Injection, 200 mcg (base)/2 mL (100 mcg (base)/mL) single-dose vials. The product is to be launched post Q1 FY16-17.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Precedex Injection, 200 mcg/2 mL, of Hospira, Inc.
Dexmedetomidine Hydrochloride Injection is used as a sedation of non-intubated patients prior to and/or during surgical and other procedures. The approved product has an estimated market size of $59.1 million for the twelve months ending January 2016 according to IMS.
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