FDA approves bupivacaine hydrochloride injection, USP

October 20, 2011

FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

Bupivacaine will be available in 6 single-dose and 2 multidose latex-free vials. According to IMS data, the 2011 US market for injectable bupivacaine approximates $29 million. As with all products in Sagent's portfolio, bupivacaine features the company's PreventIV Measures packaging and labeling designed to aid in the reduction of medication errors.

Bupivacaine is the 13th product approved under the joint venture between Sagent and Strides Arcolab. Under the collaboration, Strides is responsible for developing and supplying injectable products that Sagent will market in the United States.

Detailed information about the indications, warnings, complete side-effect profile, and full prescribing information will be available in the package insert. Visit www.SagentPharma.com for more information.