Aurobindo Pharma has received the final nod from the US health regulator to manufacture and market its anaesthetic Bupivacaine Hydrochloride injection in the American market.
The company “has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bupivacaine Hydrochloride Injection USP, 0.25 per cent (2.5 mg/mL) and 0.5 per cent (5 mg/mL) 50 mL multiple dose vials,” Aurobindo Pharma said in a filing to BSE.
This product is expected to be launched in the second quarter of the 2016-17 fiscal, it added.
The approved ANDA is generic version of Hospira Inc’s Marcaine injection, it said.
“The approved product has an estimated market size of $5.6 million for the 12 months ended March 2016, according to IMS,” it added.
Bupivacaine Hydrochloride injection is used for the production of local or regional anaesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical procedures, the company said.
The company has a total of 262 ANDA approvals (224 final approvals including 11 from Aurolife Pharma LLC and 38 tentative approvals) from USFDA, it added.
Shares of Aurobindo Pharma were trading at Rs 787.40 per scrip on BSE today, up 0.17 per cent from its previous close.