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Lupin receives FDA approval for generic TOBI inhalation solution


Lupin receives FDA approval for generic TOBI inhalation solution

Mumbai : Pharma Major Lupin Limited announced that it has received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from the United States Food and Drug Administration (FDA) to market a generic version of Novartis Pharmaceuticals Corporation’s TOBI 300 mg/5 ml.

Lupin’s Tobramycin Inhalation Solution USP, 300 mg/5 ml is the AN rated generic equivalent of Novartis Pharmaceuticals Corporation’s 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 US sales of USD 133.6 million (IMS MAT December 2016).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.



Source: Press Release
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