Zydus Naftifine HCL 2% Cream Gets CDSCO Panel nod to treat superficial fungal infection of skin
New Delhi: Pharmaceutical major, Zydus has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the antifungal drug Naftifine HCL 2% Cream for the treatment of superficial fungal infection of the skin (Tinea corporis and Tinea cruris) in the country.
This came after the firm presented the Phase III clinical trial report with proposal for grant of permission to manufacture and market the drug Naftifine HCL 2% w/w Cream before the committee.
Tinea corporis is a superficial fungal skin infection of the body caused by dermatophytes. Tinea cruris, also known as jock itch, is an infection involving the genital, pubic, perineal, and perianal skin caused by pathogenic fungi known as dermatophytes. The dermatophytes causing tinea corporis and Tinea cruris belong to genera Trichophyton, Epidermophyton, and Microsporum.
Naftifine is a synthetic, broad spectrum, antifungal agent and allylamine derivative for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.
Naftifine has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, and Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species including Candida albicans.
Naftifine was invented at the Sandoz Research Institute in Vienna, Austria. It was the first successful antifungal medication of the allylamine class.
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