Last Updated on December 31, 2023 by The Health Master
Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities, recently received final approval from the US Food & Drug Administration (USFDA) for Amphotericin B Liposome for Injection, 50 mg.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), AmBisome Liposome for Injection, 50 mg/vial, of Astellas Pharma US, Inc.
As per the statement, the product is expected to be launched by Q4 FY23. The approved product has an estimated market size of around US$ 145 million for the 12 months ending September 2022, according to IQVIA.
As per the release:
Amphotericin B Liposome for Injection is indicated as empirical therapy for presumed fungal infection in febrile, neutropenic patients, treatment of cryptococcal meningitis in HIV-infected patients, treatment of patients with Aspergillus species, Candida species
and/or Cryptococcus species infections refractory to amphotericin B deoxycholate,
or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate as well as in the treatment of visceral leishmaniasis.
In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following the initial clearance of parasites.
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