Ceptaris receives complete response letter for CTCL product

Ceptaris Therapeutics Inc. (Malvern, Pa.) said it received a complete response letter from FDA for a topical gel formulation of mechlorethamine to treat early stage mycosis fungoides, a type of cutaneous T cell lymphoma (CTCL). Ceptaris (formerly Yaupon Therapeutics Inc.), which did not disclose details of the letter, said it is working with FDA to address the agency's requests. The product is a topical form of nitrogen mustard, an alkylating agent. ...