Eugia Pharma receives US FDA nod for Amphotericin B Liposome Injection
Has an estimated market size of around US$ 145 million for the 12 months ending September 2022, according to IQVIA.
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 initial clearance of parasites.