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PET Imaging Agent Wins Approval in United States

By MedImaging International staff writers
Posted on 06 Apr 2011
A positron emission tomography (PET) imaging agent has been approved for use in the United States.

PETNET Solutions, Inc. a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. (Malvern, PA, USA), announced the approval of an Abbreviated New Drug Application (ANDA) for fluodeoxyglucose F18 Injection, United States Pharmacopeia (USP) ([18F]FDG). PETNET Solutions' submission of an ANDA, well in advance of regulatory requirements for the PET radiopharmaceutical industry, reinforces its investment in manufacturing and distribution of [18F]FDG. Siemens PETNET Solutions is the first commercial manufacturer and distributor to achieve approval of an ANDA for [18F]FDG.

"PETNET Solutions continues to set the standard in manufacturing and delivery of molecular imaging biomarkers,” said Ian Turner, CEO, Siemens PETNET Solutions. "US Food and Drug Administration [FDA] approval ensures our customers that they are receiving product that meets all regulatory and pharmacopeia requirements for safety, quality, and purity for [18F]FDG. This achievement is unique in the commercial PET radiopharmaceutical marketplace for [18F]FDG. We are committed to the highest level of quality manufacturing throughout our global network of production facilities. With the FDA approval of our ANDA for [18F]FDG, we continue to demonstrate an enduring commitment to leadership in the US market for PET radiopharmaceuticals.”

This milestone comes in parallel with PETNET Solutions' significant investments to increase its radiopharmaceutical manufacturing and distribution capabilities worldwide, and lays the foundation for quality manufacturing of new molecular imaging biomarkers as they are commercialized. PETNET Solutions operates the largest network of PET radiopharmaceutical production facilities with 54 production and distribution centers worldwide.

[18F]FDG is used in oncology for the evaluation of abnormal glucose metabolism to assist in the evaluation of known or suspected abnormalities; in cardiology, when used together with myocardial perfusion imaging to aid in identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction; and in neurology, for the identification of regions of abnormal glucose metabolism associated with epileptic seizure foci.

Because radiation-emitting products including [18F]FDG may increase the risk for cancer, particularly in pediatric patients, the smallest dose necessary for imaging should be used. In the oncology and neurology environments, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels; medical therapy and lab testing may be used to assure at least two days of normal levels prior to [18F]FDG administration. Hypersensitivity reactions with pruritus (itching), edema, and rash have been reported; therefore, emergency resuscitation equipment and personnel should be available.

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93 (617.02728271484): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (363.82675170898): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (414.84832763672): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (239.13383483887): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (667.09518432617): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (!!!!! 1002.0732879639): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (!!!!! 3998.0411529541): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (668.04885864258): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (!!!!! 1212.1200561523): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (246.04797363281): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (227.92816162109): SELECT show_live FROM jos_com_show_setting LIMIT 1
105 (382.90023803711): SELECT show_live FROM jos_com_show_setting LIMIT 1
106 (165.93933105469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
107 (!!!!! 4862.0700836182): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
108 (362.15782165527): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294734358 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
109 (833.98818969727): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294734358 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
110 (649.92904663086): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
111 (641.82281494141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
112 (298.97689819336): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294734358 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
113 (833.03451538086): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294734358 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
114 (!!!!! 7570.9819793701): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
115 (!!!!! 5526.065826416): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
116 (!!!!! 4728.0788421631): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
117 (!!!!! 6459.9514007568): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
118 (!!!!! 1866.1022186279): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
119 (412.94097900391): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
120 (591.03965759277): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
121 (53.882598876953): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
122 (595.0927734375): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
123 (598.19221496582): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
124 (437.97492980957): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
125 (!!!!! 93890.905380249): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
126 (!!!!! 1140.832901001): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294734358 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294734358 AND type='deeppockets_item' AND published='1' LIMIT 1
127 (!!!!! 50977.945327759): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
128 (!!!!! 1156.0916900635): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
129 (92.983245849609): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
130 (221.01402282715): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
131 (427.9613494873): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
132 (376.93977355957): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
133 (725.03089904785): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
134 (58.889389038086): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
135 (150.91896057129): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
136 (49.829483032227): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
137 (!!!!! 1842.0219421387): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
138 (!!!!! 1222.8488922119): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
139 (81.062316894531): SELECT name FROM jos_deeppockets WHERE id=213
140 (54.121017456055): SELECT name FROM jos_deeppockets WHERE id=213
141 (!!!!! 1383.0661773682): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
142 (!!!!! 1271.0094451904): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
143 (!!!!! 3945.1122283936): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
144 (!!!!! 6205.0819396973): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
145 (!!!!! 26479.959487915): TRUNCATE TABLE jos_trademed_module
146 (!!!!! 3023.1475830078): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294734358 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
147 (!!!!! 5490.0646209717): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294734358 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
148 (!!!!! 1795.0534820557): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
149 (528.09715270996): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
150 (235.08071899414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
151 (328.06396484375): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
152 (!!!!! 7559.061050415): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
153 (97.036361694336): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
154 (169.03877258301): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
155 (273.9429473877): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294734358 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294734358 AND type='deeppockets_item' AND published='1' LIMIT 1
156 (203.84788513184): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
157 (202.89421081543): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
158 (45.061111450195): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
159 (133.99124145508): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
160 (194.07272338867): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294734358 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294734358 AND published='1' LIMIT 1
161 (!!!!! 1533.9851379395): select jos_twitters.link from jos_twitters where cat=10
162 (!!!!! 1817.9416656494): select jos_facebook.link from jos_facebook where cat=10
163 (!!!!! 2311.9449615479): select jos_google_plus.link from jos_google_plus where cat=10
164 (104.90417480469): select jos_linkedin.link from jos_linkedin where cat=10