FDA approves Lupin generic

MUMBAI, India — The U.S. Food and Drug Administration gave final approval for Lupin’s Tobramycin Inhalation Solution USP, 300 mg/5 ml, a generic version of Novartis Pharmaceuticals’ TOBI 300 mg/5 ml.

Lupin’s Tobramycin Inhalation Solution USP, 300 mg/5 ml is the AN rated generic equivalent of Novartis Pharmaceuticals’ TOBI 300 mg/5 ml. It is indicated for the management of cystic fibrosis patients with P. aeruginosa.

Tobramycin Inhalation Solution USP, 300 mg/5 ml had U.S. sales of $133.6 million (IMS MAT December 2016).

Mumbai-based Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.