Aurobindo Pharma has received final USFDA approval to manufacture and market pre- surgery sedation injections Dexmedetomidine Hydrochloride in 200 mcg (base)/2 mL (100 mcg (base)/mL) single-dose vials. The drug is bioequivalent and therapeutically equivalent to the reference listed drug Precedex Injection, 200 mcg/2 mL, of Hospira Inc and this product is expected to be launched in the first quarter of next fiscal. The drug has an estimated market size of USD 59.1 million for the 12 months ending January 2016. Dexmedetomidine Hydrochloride Injection is used as a sedation of non-intubated patients prior to and/or during surgical and other procedures.
Company Profile : Aurobindo Pharma Ltd
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