Lupin gets USFDA nod for fungal infection drug

Mumbai based Lupin produces and develops a wide range of branded & generic formulations, biotechnology products and APIs globally

Lupin has received final approval from the US health regulator to market generic Voriconazole tablets as well as oral suspension for treatment of fungal infections in the American market.

Company's US subsidiary Gavis Pharmaceuticals LLC has received final approvals to market "its Voriconazole tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL from the United States Food and Drug Administration (FDA)," Lupin said in a filing to BSE.

The company's products are generic versions of PF Prism CV's Vfend tablets and Vfend oral suspension in the same strengths, it added.

Vfend tablets, 50mg & 200mg had US sales of $92.8 million while Vfend oral suspension, 40 mg/mL had US sales of $15.9 million according to IMS MAT March 2016, Lupin said.

Mumbai based Lupin produces and develops a wide range of branded & generic formulations, biotechnology products and APIs globally.