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Aurobindo Pharma gets US FDA nod for anaesthetic injection

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The product is expected to be launched in the second quarter of 2016-17 fiscal, it added

Aurobindo Pharma has received final nod from the US health regulator to manufacture and market its anaesthetic 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 in the US market.

The product is expected to be launched in the second quarter of 2016-17 fiscal, it added. The approved ANDA is generic version of Hospira’s Marcaine injection, it said.

The company said that the approved product has an estimated market size of
$5.6 million for the twelve months ended March 2016, according to IMS.

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 and 38 tentative approvals) from US FDA, it added.

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