The company’s 150 mg fluconazole tablets are the first in China to pass the consistency evaluation.
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发布时间:2019-05-21
【概要描述】
Recently, the company received from the National Medical Products Administration approval and issuance of the “Drug Supplementary Application Approval” for fluconazole tablets (trade name “Ilikang”) in two strengths—50 mg and 150 mg. Both strengths of this product have passed the evaluation of quality and therapeutic equivalence for generic drugs.
Recently, the Company received from the National Medical Products Administration approval for the Supplementary Drug Application for fluconazole tablets (trade name “Ilikang”) in two strengths—50 mg and 150 mg. Both strengths of this product have successfully passed the evaluation of generic drug quality and therapeutic equivalence. Notably, the 150-mg formulation manufactured by the Company is the first in China to be approved following an equivalence study conducted against the originator product as part of the consistency evaluation process.
Fluconazole tablets are triazole antifungal agents with a broad antifungal spectrum and effective against human fungal infections; their in vivo antifungal activity is markedly superior to their in vitro activity, making them widely used in clinical practice. Clinical studies have demonstrated that fluconazole is efficacious in the treatment of candidiasis, cryptococcosis, mucosal candidiasis, acute or recurrent vaginal candidiasis, and dermatophytosis, among others, and has therefore been included in the National Essential Medicines List and the National Medical Insurance Reimbursement List.
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