Nipent

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Anticancer Drugs injection pentostatin	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. SuperGen, Inc., Dublin, CA, Aug. 18 (DDMAC) by Warning Letter Bulletin 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. SuperGen Reports 2009 Third Quarter Financial Results by Business Wire 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. DDMAC UNTITLED LETTERS by Warning Letter Bulletin	Nili-Ravi nilotinib Nilstat nilutamide Nimbex NIMH nimmo/tonus receptor nimodipine nimorazole Nimotop NINDS Nine Point One Gram Lead Injection nine-mile fever ninhydrin ninhydrin reaction NINOS NINR Nintendo Surgery ninth cranial nerve niobium NIOSH niosome NIP nip & tuck Nipah virus Nipent nipper nipple nipple cancer nipple discharge nipple line nipple shield Nippon Inu Nippostrongylus braziliensis Nipride NIRD Nirenberg Nirschl procedure nirvanic state NIS nisin nisoldipine nisoldipine core coat NISS Nissen fundoplication Nissl Nissl body Nissl substance NIST NIST standard nisus	NIPARS NIPAS NIPAS Nipasol Nipasol NIPAW NIPB NIPBHA NIPBL NIPC NIPC NIPCA NIPCC NIPCCD NIPCI NIPCIP NIPCM NIPCO NIPD NIPDAU NIPDD NIPDE NIPDISC NIPDWR NIPE NIPEC NIPED Nipent NIPER NiPERA NIPERNET NIPF NIPFC NIPFer NIPFP NIPFTC NIPG NIPGM NIPGR NIPH NIPHA Niphaunda NIPHC NIPHE Nipher shield NIPHL NIPHLE NIPHP NIPHYS NIPI Nipigon Nipigon Nipigon District Memorial Hospital

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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.

SuperGen, Inc., Dublin, CA, Aug. 18 (DDMAC) by Warning Letter Bulletin

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.

SuperGen Reports 2009 Third Quarter Financial Results by Business Wire

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.

DDMAC UNTITLED LETTERS by Warning Letter Bulletin