Last Updated on December 31, 2023 by The Health Master
New Delhi: Pharmaceutical major, Mylan Pharmaceuticals has got the go ahead from the Subject Expert Committee ( SEC) of the Central Drugs Standard Control Organization (CDSCO) to import and market the antifungal medication, Liposomal Amphotericin B Injection 50mg/ml (lyophilized).
This came after the Drug Maker, MSN Pharmaceuticals, submitted the supporting data before the committee for approval of the proposed additional indications as per the recommendations of the earlier committee meeting held on 23.09.2021
Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus.
The drug acts by binding to sterols (ergosterol) in the cell membrane of susceptible fungi. This creates a transmembrane channel, and the resultant change in membrane permeability allowing leakage of intracellular components.
Ergosterol, the principal sterol in the fungal cytoplasmic membrane, is the target site of action of amphotericin B and the azoles. Amphotericin B, a polyene, binds irreversibly to ergosterol, resulting in disruption of membrane integrity and ultimately cell death.
It is used to treat fungal infections such as cryptococcal meningitis and visceral leishmaniasis. Cryptococcal meningitis is a fungal infection of the lining of the spinal cord and brain. Visceral leishmaniasis is a parasitic disease that usually affects the spleen, liver, and bone marrow.
It is also used to treat certain fungal infections in people who cannot receive conventional amphotericin B therapy. It is usually infused intravenously once daily, or for the treatment of leishmaniasis on specific days, over a period of 2 hours
At the recent Subject Experts Committee meeting for Antimicrobial and Antiviral, held on 23rd and 24th March 2022, the Committee examined the proposal meticulously.
After detailed deliberation, the committee recommended the grant of permission for import and marketing of Liposomal Amphotericin B Injection 50mg/ml (lyophilized) for the therapeutic indications which was already approved for the conventional Amphotericin B injection and the indications are as follows:
• Febrile Neutropenia in cancer patients.
• For the treatment of invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin-B therapy.
• For the treatment of visceral leishmaniasis.
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