Lupine gets FDA approval from US for the antibacterial suspension of the drug Azithromycin
The approved product – azithromycin for oral suspension, 300 mg (100 mg / 5 ml) and 1200 mg (200 mg / 5 ml) – is the generic version of the oral suspension Zithromax from Pfizer Inc
Gavis Pharmaceuticals Llc, the US subsidiary of Lupine Limited, received tentative approval for its azithromycin for oral suspension, 300 mg (100 mg / 5 mL) and 1200 mg (200 mg / 5 mL), from the Food and Drug Administration United States FDA). The approved product is the generic version of the oral suspension Zithromax from Pfizer Inc.
Lupine had received final approval of its azithromycin tablet (250 mg, 500 mg and 600 mg) and azithromycin for the oral suspension USP, 100 mg / 5 mL and 200 mg / 5 mL of the US FDA, Which was presented from its plant in Goa.
The oral suspension of Zithromax had sales of US $ 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.