Aurobindo Pharma subsidiary Eugia Pharma Specialities has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) for a generic version of Amphotericin B Liposome for Injection, 50 mg.
The product will be bioequivalent and therapeutically equivalent to reference listed drug, AmBisome Liposome for Injection, 50 mg/vial, of Astellas Pharma US, Inc. For the 12 months ended September 2022, the approved product had an estimated market size of about $145 million, Aurobindo Pharma said, citing IQVIA numbers.
A partnership product, the drug will be manufactured at TTY Biopharm Company facility in Taiwan and marketed by Eugia Pharma. The product is expected to be unveiled in the fourth quarter of FY23. Aurobindo said it is 152nd ANDA, including 10 tentative approvals received, out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Amphotericin B Liposome’s demand in India peaked during COVID when there was a spike in the number of Mucormycosis (Black fungus) cases.
The company said in a release that the drug is indicated, among others, for empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of Cryptococcal Meningitis in HIV-infected patients; and treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate.
