Claris receives US FDA approval for bupivacaine injection
Claris Lifesciences Limited has received the Abbreviated New Drug Application (ANDA) approval for bupivacaine hydrochloride in 8.25% dextrose injection USP, 7.5 mg/ml, single-dose ampules with 2ml fill volumes, in the United States of America (US).
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With this approval Claris now has a total of 15 approvals and 25 under approval ANDAs, the total addressable market size of the approved ANDAs is estimated to be a little above US$ 300 million. Claris expects more product approvals during the year, which will allow it to continue its growth in the US market.
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Bupivacaine hydroxhloride in dextorse injection is a local or regional anesthesia used as a long-acting anesthetic during surgical procedures.