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news.Yaupon Therapeutics has filed new drug application (NDA) for its gel formulation of mechlorethamine hydrochloride (mechlorethamine) with the US Food and Drug Administration (FDA).
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Mechlorethamine gel is indicated as a treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL).
The NDA submission is based in data from a multi-center clinical study evaluating topical mechlorethamine gel in patients suffering from early stage mycosis fungoides, which met its primary and secondary endpoints.
Yaupon’s mechlorethamine gel has been granted fast track and orphan drug status from the FDA.
Yaupon Chairman and CEO Steve Tullman said they look forward to collaborative discussions with the FDA during the course of the regulatory process.