Aurobindo Pharma gets USFDA nod for fungal infections tablets

By: |
New Delhi | January 27, 2016 2:49 PM

The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Voriconazole tablets in the strengths of 50 mg and 200 mg, Aurobindo Pharma said in a statement.

natco pharmaAurobindo has 233 Abbreviated New Drug Application (ANDA) approvals, (202 final approvals including 10 from Aurolife Pharma LLC and 31 tentative approvals) from USFDA. (Reuters)

Aurobindo Pharma has received approval from the US health regulator to manufacture and market generic Voriconazole tablets used for the treatment of fungal infections.

The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Voriconazole tablets in the strengths of 50 mg and 200 mg, Aurobindo Pharma said in a statement.

It expects to launch the product, generic version of PF Prism C V’s Vfend tablets in the same strengths, by March end.

“The approved product has an estimated market size of USD 103 million for the twelve months ending November 2015 according to IMS,” the company said.

Aurobindo has 233 Abbreviated New Drug Application (ANDA) approvals, (202 final approvals including 10 from Aurolife Pharma LLC and 31 tentative approvals) from USFDA.

The company’s stock was trading at Rs 805.50, down 1.51 per cent, on the BSE.

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