Aurobindo Pharma receives USFDA approval for anaesthetic injection

Aurobindo Pharma has received 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% (2.5 mg/mL) and 0.5% (5 mg/mL) 50 mL multiple dose vials," Aurobindo Pharma said in a filing to the BSE.

This product is expected to be launched in the second quarter of 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 twelve 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.

On Monday, shares of Aurobindo Pharma were trading at Rs 787.40 per scrip on the BSE, up 0.17% from its previous close. However, at 1251 hours, there was a slight drop in the shares on the BSE, trading at Rs 785, down Rs 1.05 or 0.13%.