Aurobindo Pharma receives USFDA approval for Bupivacaine Hydrochloride Injection

16 May 2016 Evaluate

Aurobindo Pharma 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. This product is expected to be launched in Q2 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Marcaine Injection, 0.25% and 0.5% of Hospira, Inc.

Bupivacaine Hydrochloride Injection is used for the production of local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical procedures. The approved product has an estimated market size of $5.6 million for the twelve months ending March 2016, according to IMS.

This is the 32nd ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 262 ANDA approvals (224 Final approvals including 11 from Aurolife Pharma LLC and 38 tentative approvals) from USFDA.


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