Mylan gets CDSCO nod to import and market Liposomal Amphotericin B Injection
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).
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
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.
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