SuperGen Mitozytrex approval
This article was originally published in Pharmaceutical Approvals Monthly
SuperGen will emphasize increased safety and stability with Mitozytrex against generic mitomycin. The firm's proprietary formulation of mitomycin, using its Extra technology, clears FDA Nov. 14 as adjunctive therapy for disseminated adenocarcinoma of the stomach or pancreas and as palliative treatment when other modalities have failed. Mitozytrex is the first of SuperGen's "supergenerics" using Extra, which limits the solubility of toxic agents through starch encapsulation (Pharmaceutical Approvals Monthly, November 2002, p. 6
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