Aurobindo Pharma receives USFDA approval for Voriconazole Tablets

27 Jan 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Voriconazole Tablets, 50 mg and 200 mg. This product is expected to be launched in Q4 FY15-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) VFEND Tablets, 50 mg and 200 mg of PF Prism C.V. (Prism).

Voriconazole Tablets is used in the treatment of fungal infections for patients 12 years of age and older. The approved product has an estimated market size of $103 million for the twelve months ending November 2015 according to IMS.

This is the 59th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 233 ANDA approvals (202 Final approvals including 10 from Aurolife Pharma LLC and 31 Tentative approvals) from USFDA.



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