The pharmaceutical company revealed on Friday that Amphotericin B Liposome for Injection has acquired final FDA approval through its wholly owned subsidiary, Eugia Pharma Specialties.
Amphotericin B Liposome for Injection is recommended for visceral leishmaniasis treatment, cryptococcal meningitis treatment in HIV-infected individuals, and empirical therapy for suspected fungal infection in feverish, neutropenic patients.
Amphotericin B Liposome for Injection would be therapeutically and bioequivalently equivalent to Astellas Pharma US, Inc.’s AmBisome Liposome for Injection, which is a reference listed drug (RLD).
The product is anticipated to be released by Q4 of FY23, according to the pharmaceutical firm. The market size for the approved product is anticipated to be roughly $145 million for the twelve months ending September 2022, according to IQVIA.