Aurobindo Pharma receives USFDA final approval for Flucytosine Capsules

Aurobindo Pharma 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 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 3rd 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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