Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Flucytosine Capsules, 250 mg and 500 mg. Flucytosine Capsules are generic version of Bausch Health’s Ancobon® Capsules. The product will be launched in June 2020.
The approved product has an estimated market size of US$ 43 million forthe twelve months ending March 2020, according to IQVIA. Flucytosine Capsules are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
This is the 3 rd ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 429 ANDA approvals (401 Final approvals including 23 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
