Aurobindo Pharma gets USFDA approval for Flucytosine capsules

Aurobindo Pharma Limited announced that it has received a final approval from 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. Flucytosine capsules are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.

The yeasts-Candida and Cryptococcus are important human opportunistic pathogens. Candida relies on skin or mucosal breach to cause bloodstream infection whereas, Cryptococcus exploits depressed cell-mediated immunity characteristic of advanced HIV infection.

According to IQVIA data for the twelve months ending March 2020, the approved product has an estimated market size of US$ 43 million.

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.

On Monday, the stock of Aurobindo Pharma opened at Rs 618.85. In the morning trading session, it jumped 8.8 per cent to Rs 681 from its previous close of Rs 625.95.