Aurobindo receives US FDA nod for bacterial infection drug

MUMBAI: Drug maker Aurobindo Pharma on Monday said that it has received the US regulatory approval for its Cefazolin injection, used in the treatment of bacterial infections.

The company has received final approval from the US Food and Drug Administration (US FDA) for 500 mg and 1 gram per vial of Cefazolin injection, Aurobindo Pharma said in a filing to the Bombay Stock Exchange.

The injection is a Sterile Cephalosporin product under the anti-infective segment and is a generic equivalent to Abraxis Pharmaceutical Products' reference listed drug Cefazolin, the filing said.

Cefazolin Injection, is used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Cefazolin injection is the third product approved by the US FDA of the Sterile Injectable Formulation, it said.

Last week the pharmaceutical company had received US FDA approval to manufacture and market Alendronate Sodium tablets, used in the treatment of bone diseases, in that country.

With this, the number of Abbreviated New Drug Application (ANDA) approvals from the US FDA stands at 74, the filing added.

Shares of Aurobindo Pharma were trading at Rs 305.20, up 1.72 per cent in the afternoon trade on BSE.