CDSCO Panel Accepts Mylan's Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended to accept the Mylan Pharmaceutical's Post Marketing Surveillance study report of Liposomal Amphotericin B for Injection 50mg.
This came after the firm presented the Post Marketing Surveillance study report for the study no. GS-US-131-6403 version no.1.0 dated 23.09.2024 of Liposomal Amphotericin B for Injection 50mg/vial before the committee.
Amphotericin B is a broad-spectrum antifungal medication used to treat serious fungal infections and leishmaniasis. It's considered a "gold standard" antifungal drug and is particularly effective for treating severe systemic fungal infections.
Amphotericin B exerts its antifungal effect by disruption of fungal cell wall synthesis because of its ability to bind to sterols, primarily ergosterol, which leads to the formation of pores that allow leakage of cellular components. This affinity may also account for its toxic effects against select mammalian cells.
Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people.
At the recent SEC meeting for Antimicrobial and Antiviral held on 14th May 2025, the expert panel reviewed the Post Marketing Surveillance study report for the study no. GS-US-131-6403 version no.1.0 dated 23.09.2024 of Liposomal Amphotericin B for Injection 50mg/vial before the committee.
After detailed deliberation, the committee recommended to accept the Post Marketing Surveillance study report of Liposomal Amphotericin B for Injection 50mg.
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