Aurobindo Pharma receives USFDA approval for Flucytosine Capsules

Aurobindo Pharma announced that the company 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 a 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 $ 43 million for the 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 third 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.

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