Strides Pharma gets USFDA approval to sell Flucytosine capsules to treat rare fungal infection
India-based Strides Pharma has received approval from the United States Food and Drug Administration (USFDA) to market Flucytosine capsules
India-based Strides Pharma has received approval from the United States Food and Drug Administration (USFDA) to market Flucytosine capsules.
The capsules, which comes in sizes of 250 mg and 500 mg, will be manufactured at the company’s Bengaluru plant. Flucytosine capsule is used in the treatment of serious infections caused by susceptible strains of candida and cryptococcus.
According to Centers for Disease Control and Prevention (CDC), candida is a type of fungus which causes candidiasis infection. It normally lives on the skin and inside the body without causing any problems. The fungus causes infection when it enters into the bloodstream or internal organs like the kidney, heart or brain.
The cryptococcus fungus causes the disease cryptococcosis. There are two species of this fungus that causes infection in humans - cryptococcus neoformans and cryptococcus gatti. Both are spread through inhalation and could cause fever, malaise, headache, neck stiffness, photophobia, nausea and vomiting.
DailyMed, which is the official provider of FDA label information, says Flucytosine capsules should be used in combination with amphotericin B. It also suggests that the capsules should not be given to persons with a known hypersensitivity to the drug.
Flucytosine capsules are generic version of Ancobon capsules of Bausch Health. The market of the product in the US is approximately worth $45 million.
Strides Pharma says it has 123 cumulative Abbreviated New Drug Application (ANDA) filings with USFDA. Of these, 86 ANDAs have been approved and 37 are pending approval.
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