FDA approves Lupin generic

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FDA approves Lupin generic

By Brian Berk - 03/23/2017

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.


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