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).
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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