Tuesday, 26 July 2016

Claris Life gets USFDA nod for generic Bupivacaine anesthetic injection

Drug firm Claris Lifesciences has received approval from the US health regulator for generic anesthetic Bupivacaine injection.

The company has received approval from the United States Food and Drug Administration (USFDA) for generic "Bupivacaine hydrochloride in 8.25 per cent dextrose injection USP 7.5 mg/mL, single dose ampules with 2 ml fill volumes," Claris Lifesciences said in a BSE filing.

The injection is indicated for the production of local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures.
With this approval the company has 15 approvals and 25 under approval abbreviated new drug applications (ANDAs), Claris Lifesciences said. The company expects more product approvals during the year, it added.



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