Drug firm Aurobindo Pharma on Thursday said it has received final nod from the US health regulator for its Azithromycin Oral suspension used for treatment of infections.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Azithromycin Oral suspension 100 mg /5 mL and 200 mg/5 mL, Aurobindo Pharma said in a statement.
The product is a generic version of Pfizer Inc’s Zithromax oral suspension, it added.
“The product will be launched in November 2018,” Aurobindo Pharma said.
Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections, it added.
According to IQVIA, the approved product has an estimated market size of USD 71 million for the 12 months ending August 2018, Aurobindo Pharma said.
The company now has a total of 386 abbreviated new drug application (ANDA) approvals (357 final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from the USFDA, it added.
Shares of Aurobindo Pharma were trading at Rs 773.75 per scrip on the BSE, down by 0.58 per cent from its previous close.