Aurobindo Pharma has received final approval from the US Food and 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.
This is the 3rd ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India used for manufacturing oral products. The company now has a total of 429 ANDA approvals (401 Final approvals including 23 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
