New Delhi: Aurobindo Pharma has received final approval from the USFDA to manufacture and market pre- surgery sedation injections Dexmedetomidine Hydrochloride.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride Injection, 200 mcg (base)/2 mL (100 mcg (base)/mL) single-dose vials,” Aurobindo Pharma said in a BSE filing today.
The company said the approved ANDA 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 approved product has an estimated market size of USD 59.1 million for the 12 months ending January 2016 according to IMS, Aurobindo Pharma said.
Dexmedetomidine Hydrochloride Injection is used as a sedation of non-intubated patients prior to and/or during surgical and other procedures.
Aurobindo Pharma has a total of 244 ANDA approvals (209 final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from the US.