Areva to Import Bupivacaine from Italy

Areva Pharmaceuticals in conjunction with FDA has initiated a temporary importation of bupivacaine hydrochloride injection 0.25% and 0.5% into the U.S. market to address a drug shortage. Bupivacaine hydrochloride is an anesthetic that is used for local anesthesia, given epidurally, or for dental procedures.

The company is making available 5 mL and 10 mL bupivacaine hydrochloride single dose ampules manufactured by its supplier, Fisiopharma, in Italy.

At this time, no other company except Areva is authorized by the FDA to distribute bupivacaine hydrochloride. The regulatory agency has not approved this product manufactured by Areva's supplier.

This is the Areva’s second importation of bupivacaine this year. In February, the company also initiated a importation program in February 2021.

Several other companies have also had shortages of bupivacaine hydrochloride over the last year, including AuroMedics Pharma, Baxter, Fresenius Kabi and Hospira. These companies indicated the shortages are a result of both increased demand and manufacturing delays. Fresenius Kabi and Hospira are also experiencing shortages of the combination bupivacaine hydrochloride and epinephrine.

Areva will be offering several products through its distributors McKesson, Cardinal Health, and AmerisourceBergen, including:

Bupivacaine hydrochloride injection, 2.5 mg/mL (0.25%)

• 5 mL glass ampule with NDC 59923-717-05

• 10 mL glass ampule with NDC 59923-719-10

Bupivacaine hydrochloride injection, 5 mg/mL (0.5%)

• 5 mL glass ampule with NDC 59923-718-05

• 10 mL glass ampule with NDC 59923-720-10