Eugia Pharma Specialities gets FDA OK for generic AmBisome Liposome for Injection

Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities, has obtained the Food and Drug Administration’s clearance for amphotericin B liposome for injection, 50 mg /vial, which is a generic of Astellas’ AmBisome Liposome for Injection.

This is a partnership product from TTY Biopharm and will be manufactured at their Taiwan facility and marketed by Eugia Pharma.

[Read more: Eugia Pharma obtains FDSA blessing for generic Nolvadex] 

Amphotericin B liposome for injection is indicated for the following conditions: 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 (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B Deoxycholate; and 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.

[Read more: Aurobindo obtains FDA approval for generic Colcrys]

The approved product has an estimated market size of roughly $145 million for the 12 months ending September 2022, according to IQVIA.

It is expected to be launched by Q4 FY23.