Claris receives approval for fluconazole injection in 50 ml PVC bags in US

Claris Lifesciences has received supplemental abbreviated new drug application (ANDA) approval from the US Food & Drug Administration (US FDA) for fluconazole injection in 50 ml PVC bags. The company has received the supplemental ANDA approval for fluconazole injection in the US, said Claris in a press release.
 
Claris, which currently markets fluconazole in 2 mg/ml formulation packed in 100 ml and 200 ml PVC bags, is the only company to be able sell fluconazole in 50 ml variant in the US after it received the latest approval.
 
The company has 13 ANDAs approved across 8 molecules in the US. Claris has a under registraton pipeline of 25 ANDAs across 22 molecules having an estimated addressable market size of $ 2.2 billion.