Aurobindo Pharma announces FDA final approval for Amphotericin B Liposome for Injection
Aurobindo Pharma said that its fully-owned subsidiary — Eugia Pharma Specialities has secured final approval for Amphotericin B Liposome for Injection, 50 mg from the US Food & Drug Administration (FDA).
The approved product is bioequivalent and therapeutically equivalent to Astellas Pharma US’ AmBisome Liposome for Injection, 50 mg/vial.
Amphotericin B Liposome for Injection is indicated for presumed fungal infection in febrile, neutropenic patients as an empirical therapy, for the treatment of cryptococcal meningitis in HIV-infected patients, Aspergillus species, Candida species and/or Cryptococcus species infections, and treatment of visceral leishmaniasis.
Aurobindo Pharma expects to launch the generic product in the US by Q4 FY23. The Indian pharma company said that Amphotericin B Liposome for Injection is a partnership product from TTY Biopharm Company, which will be manufactured at the latter’s Taiwanese facility, while the marketing will be done by Eugia Pharma.
According to IQVIA, the approved drug has an estimated market size of nearly $145 million for the 12 months ending September 2022.
Aurobindo Pharma, in a filing to NSE India, stated: “This is the 152nd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.”