Lupin receives US FDA approval for tobramycin inhalation solution

Lupin Limited has received final approval for its tobramycin inhalation solution (300 mg/5 ml) from the US Food and Drug Administration (FDA). The approved product is the generic version of Novartis Pharmaceuticals Corporation’s Tobi.

Lupin’s tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with P. aeruginosa.

According to IMS MAT December 2016 data, tobramycin inhalation solution (300 mg/5 ml) had US sales of $ 133.6 million.