Eugia Pharma Receives USFDA Approval for Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial

Eugia US is pleased to announce that the company has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial.

Indications for this product include:

• 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.
• 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.

Refer to package insert for full prescribing information.