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Lupin Receives FDA Approvals for Generic Vfend® Tablets 50mg, 200mg & Vfend® Oral Suspension, 40 mg/mL

 

Mumbai, Baltimore, June 6, 2016: Pharma Major Lupin Limited announced today that its 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 (FDA) 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 the following fungal infections:

 

  • Invasive Aspergillosis
  • Candidemia in Non-neutropenic patients and the following Candida infections: Disseminated infections in skin and infections in abdomen, kidney, bladder wall and wounds
  • Esophageal Candidiasis
  • Serious fungal infections caused by Scedosporium apiospermum (Asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of or refractory to other therapy

 

Vfend® Tablets, 50mg & 200mg had US sales of USD 92.8 million (IMS MAT March 2016) while Vfend® Oral Suspension, 40 mg/mL had US sales of USD 15.9 million (IMS MAT March 2016).

 

About Lupin Limited

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing 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 positions in the Anti-TB and Cephalosporin segment.

Lupin is the 6th largest and fastest growing top 10 generics player in the US (5.5% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales globally. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan (ranked 9th) and South Africa (ranked 4th – IMS Health).

For the financial year ended 31st March 2016, Lupin’s Consolidated turnover and Profit after Tax were Rs. 137,016 million (USD 2.09 billion) and Rs. 22,707 million (USD 347 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited

CIN: L24100MH1983PLC029442 Registered Office: Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai – 400 055.

 

For further information or queries please contact:

Shamsher GorawaraHead – Corporate CommunicationsLupin Limited
Ph: +91 98 20 338 555
Email: shamshergorawara@lupin.com

 

*Safe Harbor Statement

Vfend® is the registered trademark of Pfizer Ireland Pharmaceuticals