Lupin’s US subsidiary, Gavis Pharmaceuticals LLC., (collectively Lupin) has received final approvals for its Voriconazole Tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL from the United States Food and Drug Administration (USFDA) to market a generic equivalent of PF Prism C.V’s Vfend Tablets, 50 mg & 200 mg and Vfend Oral Suspension, 40 mg/mL. Lupin shall commence promoting the products in the US shortly.
Voriconazole Tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL are the AB rated generic equivalent of PF Prism C.V's Vfend Tablets, 50 mg & 200 mg and Vfend Oral Suspension, 40 mg/mL. It is indicated for use in patients 12 years of age and older in the treatment of fungal infections.
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, as per IMS MAT March 2016.