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Aurobindo Pharma gets FDA nod to launch anesthesia drug in US

Livemint:  May 17, 2016

Hyderabad: Aurobindo Pharma Ltd on Monday said it has got final approval from the US Food and Drug Administration (FDA) to sell anesthesia drug bupivacaine hydrochloride in the US.

The approved abbreviated new drug application (ANDA) is a version of US-based Hospira Inc.’s Marcaine injection, in 0.25% (2.5 mg/ml) and 0.5% (5 mg/ml) dosage forms.

This product is expected to be launched in the second quarter of this financial year, the company said.

Bupivacaine hydrochloride injection is used for the production of local or regional anesthesia or analgesia for surgical, diagnostic and therapeutic procedures, as well as for obstetrical procedures.

The approved product has an estimated market size of $5.6 million for the 12 months ended March 2016, Aurobindo said citing US-based healthcare information provider IMS Health.

This is the 32nd ANDA, including two tentative approvals, to come out of the Unit IV formulation facility in Hyderabad, the company said.

Aurobindo now has a total of 262 ANDA approvals from FDA.

Shares of Aurobindo rose 0.37% and were trading at Rs.788.95 each on the BSE at 15:10, when the benchmark Sensex gained 0.63% and was trading at 25,648.92 points.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.