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Aurobindo Pharma gets USFDA nod for infections treatment drug

Press Trust of India  |  New Delhi 

Drug firm Thursday said it has received final nod from the US health regulator for its oral suspension used for treatment of

The company has received final approval from the (USFDA) to manufacture and market oral suspension 100 mg /5 and 200 mg/5 mL, 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," said.

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 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.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, October 11 2018. 13:40 IST