FDA approves Sagent bupivacaine hydrochloride injection - Clinical Trials Arena
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FDA approves Sagent bupivacaine hydrochloride injection

25 Oct 2011

The US Food and Drug Administration (FDA) has granted approval for Sagent Pharmaceuticals' bupivacaine hydrochloride injection.

The US Food and Drug Administration (FDA) has granted approval for Sagent Pharmaceuticals’ bupivacaine hydrochloride injection.

The drug is indicated for the production of local or regional anaesthesia or analgaesia for dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

Developed by Strides Arcolab, the injection will be available in six single-dose and two multi-dose latex-free vials.

Strides is responsible for developing and supplying injectable products that Sagent will market in the US.