Aurobindo Pharma has received US Food and Drug Administration (USFDA) approval to manufacture and market Voriconazole tablets (50 mg and 200 mg) that are used to treat fungal infections.
Announcing this on Wednesday, the company said that it expected to launch the product by March.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product VFEND tablets of PF Prism C.V.
For the 12 months ending November 2015, the product had an estimated market size of $103 million the company said citing IMS. This is the 59th ANDA to be approved out of Aurobindo Pharma’s Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
The company now has a total of 233 ANDA approvals from USFDA, a release said.
