ARTICLE | Clinical News
Kevetrin regulatory update
December 19, 2011 8:00 AM UTC
Cellceutix said FDA reviewed an IND for Kevetrin and advised it that the batch formulation of the cancer product needs to be redone after operations were ceased at contract manufacturer Formatech Inc. (Andover, Mass.). Cellceutix said it already has identified an alternative formulation site, with production slated for next month. In March 2010, Cellceutix partnered with Formatech to develop Kevetrin as a lyophilized powder for reconstitution in saline solution at the time of use (see BioCentury, March 29, 2010). Formatech filed for bankruptcy in August. ...