Gel given orphan drug status in Europe for CTCL


The privately held specialty pharmaceutical company Ceptaris Therapeutics has announced that the European Medicines Agency (EMA) has given Orphan Drug Designation to the company's investigational drug chlormethine gel (known as mechlorethamine gel in the United States) for the treatment of Cutaneous T-Cell Lymphoma (CTCL).

The gel was previously granted orphan drug status in the US by the US Food and Drug Administration.

The FDA is currently reviewing the New Drug Application (NDA) submitted by Ceptaris Therapeutics in July 2011 for mechlorethamine gel for the treatment of early stage favorable mycosis fungoides, a subtype of Cutaneous T-Cell Lymphoma (CTCL).

Source: MarketWatch

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