Lupin receives tentative approval for generic Zithromax oral suspension

It is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria

Lupin’s US subsidiary, Gavis Pharmaceuticals US has received tentative approval for its Azithromycin for oral suspension USP, 300 mg (100 mg/5 mL) and 1200 mg (200 mg/5 mL) from the United States Food and Drug Administration (USFDA) to market a generic version of Pfizer’s Zithromax for oral suspension, 100 mg/5ml and 200 mg/5ml. Lupin had earlier received final approval for its Azithromycin tablets, 250 mg, 500 mg, 600 mg and Azithromycin for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL from the FDA which was filed from its Goa plant.

Azithromycin for oral suspension USP, 300 mg (100 mg/5ml) and 1200 mg (200 mg/5ml) per bottle are the AB rated generic equivalent of Pfizer Inc’s Zithromax for oral suspension, 100 mg/5ml and 200 mg/5ml. It is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria.

Zithromax Oral Suspension had US sales of $110.6 million (IMS MAT June 2016).