Sun Pharmaceutical wins FDA approval for generic Amphotericin B Liposome

Sun Pharmaceutical Industries said that one of its fully-owned subsidiaries has secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial.

According to the Indian pharma company, the generic product approval is based on AmBisome Liposome for Injection, 50 mg/vial as a reference product, which is used for the treatment of fungal infections like cryptococcal meningitis and visceral leishmaniasis.

Sun Pharmaceutical said that it has been given competitive generic therapy (CGT) designation from the FDA and being the first approved generic, the drug qualifies for 180 days of CGT exclusivity.

AmBisome Liposome for Injection, 50mg/vial had annualized sales of around $136 million in the US as per October 2021 IQVIA Health data.