Lupin arm gets tentative FDA nod for anti-bacterial drug

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New Delhi | Published: September 1, 2016 4:50:11 PM

Drug firm Lupin today said US-based subsidiary Gavis Pharmaceuticals has received tentative approval from the USFDA for Azithromycin for oral suspension, an anti-bacterial drug, in the American market.

Gavis has received tentative approval for its Azithromycin for oral suspension USP from the United States Food and Drug Administration (FDA), Lupin said in a BSE filing. (Source: Reuters)

Drug firm Lupin today said US-based subsidiary Gavis Pharmaceuticals has received tentative approval from the USFDA for Azithromycin for oral suspension, an anti-bacterial drug, in the American market.

Gavis has received tentative approval for its Azithromycin for oral suspension USP from the United States Food and Drug Administration (FDA), Lupin said in a BSE filing.

The company’s product is a generic version of Pfizer Inc’s Zithromax and is indicated for mild to moderate infections caused by bacteria.

As per IMS MAT sales data, Zithromax Oral Suspension had US sales of $110.6 million.

Shares of Lupin today ended 1.21 per cent up at Rs 1,501.60 on BSE.

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