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Nipent

   Also found in: Wikipedia 0.01 sec.
Nipent®
Pentostatin, see there


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In what was entitled an "Enforcement Letter," CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) reviewed a mechanism of action (1VIOA) booth panel and handout for Nipent (pentostatin) for Injection and found them to be false or misleading because they failed to present any risk information, overstated the efficacy and safety, and made unsubstantiated claims regarding the method of action for the drug.
The gain on sale of products for both periods primarily relate to the receipt of additional payments resulting from the sale of the worldwide rights for Nipent to Mayne Pharma (acquired by Hospira, Inc.
10403W) cited the firm's reprint carrier and journal ad for Nipent (pentostatin), a treat-ment for untreated and alpha-interferon-refractory hairy-cell leukemia, for claims of a 67% ten-year relapse-free survival rate and an 81% ten-year overall survival rate that were "derived from the Finn study (which) are not sup-ported by sub-stantial evidence.
 
 
 
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