Claris Lifesciences Ltd, on Tuesday, said it has received the Abbreviated New Drug Application (ANDA) approval from the USFDA for a local anaesthesia drug, Bupivacaine Hydroxhcloride.
With this, Claris now has a total of 15 approvals and 25 under-approval ANDAs. The total market size of the approved ANDAs is estimated to be over $300 million. Claris expects more product approvals during the year, which will allow it to continue its growth in the US market, the company said in a release.
Bupivacaine Hydroxhloride in dextrose injection is a local or regional anesthesia used as a long-acting anesthetic during surgical procedures. It will be available in 8.25% dextrose injection USP, 7.5 mg/mL, single-dose ampules with 2ml fill volumes, in the US.
Published on July 26, 2016
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