Lupin gets US FDA nod for antibacterial drug azithromycin suspension

Gavis Pharmaceuticals Llc, the US subsidiary of Lupin Limited, has received tentative approval for its azithromycin for oral suspension, 300 mg (100 mg/5 mL) and 1200 mg (200 mg/5 mL), from the US Food and Drug Administration (FDA). The approved product is the generic version of Pfizer Inc’s Zithromax oral suspension.

Lupin had earlier received final approval for its azithromycin tablet (250 mg, 500 mg & 600 mg) and azithromycin for oral suspension USP, 100 mg/5 mL and 200 mg/5 mL from the US FDA which was filed from its Goa plant.

Zithromax oral suspension had US sales of $ 110.6 million, according to IMS MAT June 2016.

Azithromycin, an antibiotic, is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria.