Express Pharma

Claris gets US FDA supplemental nod for Fluconazole injection

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Fluconazole injection in 50 ml PVC bags, is used for treating fungal infections, in the American market

Claris Lifesciences has received supplemental approval from the US health regulator to market Fluconazole injection in 50 ml PVC bags, used for treating fungal infections, in the American market, according to a report in PTI.

“The company has received the supplemental Abbreviated New Drug Application (ANDA) for Fluconazole injection in the US,” Claris Lifesciences said in a filing to the BSE.

The firm is already marketing Fluconazole in 2 mg/ml formulation packed in 100 ml and 200 ml PVC bags, it added. The company markets its products through a wholly-owned subsidiary Claris Lifesciences, it said.

At present, the company has 13 approved ANDAs while 25 ANDAs are in the registration pipeline, it added.

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