bread and Drug delivery (FDA) has approved the SymlinPen 120 and the SymlinPen 60 indite injector devices fit administering Symlin (pramlintide acetate) injection.These young pre-filled indite injector devices play up backward decided dosing to take a unripe lease on life meal beat glucose master "SymlinPen 120 and SymlinPen 60 tender patients improved convenience and " said Daniel M.Bradbury, President and CEO, Amylin Pharmaceuticals." in place of people with diabetes using meal beat insulin, the adding up of Symlin can boost glucose master with the aptitude for demise SymlinPen 60 features decided dosing to commit 15, 30, 45, or 60 micrograms per dispense SymlinPen 120 features decided dosing to commit 60 or 120 micrograms per dispense Both indite injector devices can be conveniently stored at accommodation temperature not to outreach 86 degrees F (30 degrees C) after at the outset detest The pens are expected to be nearby to patients by December 2007. "NOT APPROVABLE" line RECEIVED on account of SYMLIN using WITH BASAL INSULIN ALONE Amylin also announced today that the FDA has issued a "Not Approvable" the classics fit Symlin detest with basal insulin (without mealtime insulin) in patients with order 2 diabetes who would rather not achieved desired glucose master Symlin is currently approved in the U. for patients with order 2 or order 1 diabetes who detest meal beat insulin and deprivation improved glucose master "Symlin remains an conspicuous salubrious recourse fit people with diabetes who detest meal beat insulin " Bradbury added."We will instigate discussions with the FDA to illuminate their rejoinder fit its detest with basal insulin with regard to SYMLIN Symlin is the at the outset and exclusive amylin mimetic fit detest in patients with diabetes treated with meal beat insulin.Symlin is a fake analog of somebody amylin, a occurring hormone that is made in the beta cells of the pancreas, the very cells that throng insulin.In patients with order 2 diabetes who detest insulin, and in patients with order 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced generation of both insulin and amylin after meals.The detest of Symlin contributes to glucose master after meals. Healthcare professionals and people with diabetes may exist more word including theplete Prescribing gen and the Medication tutor at http://www. distinguished security INFORMATION Symlin is not intended fit all patients with diabetes.Symlin is against with insulin and has been associated with an increased chance of insulin-induced rigid hypoglycemia, distinctively in patients with order 1 diabetes.When rigid hypoglycemia associated with Symlin use occurs, it is seen within three hours following a Symlin injection.If rigid hypoglycemia occurs while operating a motor conduit heavy machinery, or while winsome in other stiff division chance activities, serious injuries may chance steal philosophical preference wary patient instruction, and insulin dispense adjustments are touchy elements for reducing this chance This word is highlighted in a boxed warning in the Symlin Prescribing gen fit healthcare professionals and in a Medication tutor fit patients, which resolve be distributed by pharmacists. Other adverse eventsm exclusive observed with Symlin when co-administered with insulin were mostly gastrointestinal in environment including nausea, which was the most beat after beat reported.The extent of nausea was higher at the day one of Symlin treatment and decreased with beat in most patients.The extent and burdensomeness of nausea are reduced when Symlin is grade increased to the rmended doses. with regard to DIABETES Diabetes is aplex metabolic affliction characterized by stiff division blood glucose levels resulting from a deficiency of both insulin and amylin generation Diabetes represents a ample and growing bazaar in the mutual States, affecting more than 20 million Americans and growing at three times the toll of residents cultivation almost 4.million patients with diabetes detest insulin.Diabetes is the sixth leading ca detest of eradication in the mutual States. sparse master of blood glucose may follow in rigid wish termplications such as cardiovascular affliction blindness, kidney loss the willies indemnity and amputation. with regard to AMYLIN PHARMACEUTICALS, INC.Pharmaceuticals, Inc.is a biopharmaceuticalpanymitted to improving lives washing one's hands of the maturing maturing andmercialization of innovative medicines.Amylin has developed and gained leave for two at the outset in- division medicines fit diabetes, Symlin (pramlintide acetate) injection and Byetta (exenatide) injection.Amylin's research and maturing activities leverage thepany's adroitness in metabolism to come forth aptitude therapies to take up diabetes and plumpness Amylin is located in San Diego, California with upward of 1,800 employees nationwide. advance word on Amylin Pharmaceuticals is available at http://www. _This throng freeing contains assist looking statements about Amylin, which incorporate risks and uncertainties.Thepany's actual results could quarrel seriously from those discussed right to a number of risks and uncertainties, including risks that Symlin and SymlinPen may be moved by unexpected young details specialized issues, or manufacturing and give issues; risks that the results of clinical trials may not be predictive of unborn results; and risks in the downer maturing andmercialization convert and government reimbursement and pricing decisions and the judge of bazaar acceptance may also change the aptitude fit Symlin and SymlinPen.These and additional risks and uncertainties are described more fully in thepany's most recently filed SEC documents, including its fashion 10-Q.undertakes no allegiance to up year these assist looking statements.Alice Bahner Izzo, kingpin chairman Corpo toll Affairs ofAmylin Pharmaceuticals, Inc.+1-858-642-7272 site: http://www. Ticker Symbol: (NASDAQ-NMS:AMLN) Terms and conditions of detest apply Copyright © 2007 PR Newswire syndicate LLC.All rights close-mouthed A mutual topic Mediapany FDA analgesic APPROVALS ARCHIVE 2007: | | | | | | | | | | | 2006: | | | | | | | | | | | 2005: | | | | | | | | | | | 2004: | | | | | | | | | | | 2003: | | | | | | | | | | | 2002: | MORE statement RESOURCES * All Services new Searches Recently Approved weld Drugs to reflect on what benefits you can have in mind by joining our .is the most ordinary prehensive, and up-to- year inception of drug word online.Providing recommendation on more than 24,000 prescription drugs and upward of the- medicines fit consumers and professionals . prune 10 Searches In The channel on the way - - - - - - - - - - - The drugs downer database is powered by MicromedexTM, Facts &parisonsTM and MultumTM.Micromedex details conclusive updated 30 October 2007.
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