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Lupin receives USFDA approvals for generic Vfend tablets and Oral Suspension

06 Jun 2016 Evaluate

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.


Peers
Company Name CMP
Sun Pharma. Inds. 1810.00
Dr. Reddys Labs. 1200.10
Cipla 1346.85
Lupin 2029.00
Zydus Lifesciences 1145.25
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