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Map Pharmaceuticals Plans FDA Meeting To Discuss Manufacturing Issues

DOW JONES NEWSWIRES Map Pharmaceuticals Inc. (MAPP) plans to meet with the Food and Drug Administration during the current quarter to discuss manufacturing issues that are preventing approval of its migraine medication Levadex. The FDA in March sent a complete response letter to the biopharmaceutical company that required Map Pharmaceuticals to address manufacturing issues, chemistry and controls issues found in an inspection of the drug maker's third-party manufacturer. Investors have been awaiting the agency's decision on the usability of Map's inhalable drug, which delivers a common migraine treatment in an aerosol format. President and Chief Executive Timothy S. Nelson said the company continues to work closely with partner Allergan Inc. (AGN), as it seeks to resolve the issues as quickly as possible. Allergan has a deal with Map Pharmaceuticals to jointly promote Levadex. The company also announced that it recently was issued a third patent related to Levadex. Map shares closed Thursday at $13.14, down 1.2%, and were inactive in after-hours trading. The stock is off nearly 27% from a 2-year high last month before the company received the FDA's complete response letter. -By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com

Stock News for Map Pharmaceuticals (MAPP)
DateTimeHeadline
02/05/201310:00:42Allergan 4th-Quarter Profit Rose 16% Amid Growing Revenue, Fewer...
01/23/201309:01:48Allergan Looks To Boost Migraine Sales With MAP Purchase
01/22/201322:40:11Allergan to Buy MAP Pharmaceuticals for $958 Million
08/01/201209:36:08US HOT STOCK FUTURES: HOT STOCKS TO WATCH
08/01/201206:58:34U.S. HOT STOCK FUTURES: HOT STOCKS TO WATCH
06/25/201208:07:14MAP Pharmaceuticals to Resubmit Application for Migraine Treatment...
04/13/201209:13:28US STOCK FUTURES: HOT STOCKS TO WATCH
04/12/201217:32:08Map Pharmaceuticals Plans FDA Meeting To Discuss Manufacturing...
03/27/201210:57:22MAP Confident In Levadex, Plans Swift Response To FDA
02/02/201114:08:23Allergan CEO: Would Consider Expanded Agreement On Levadex
02/02/201110:12:04Allergan 4Q Profit Up 19%; EPS Outlooks Miss Street Forecasts
01/31/201113:40:44CORRECT: Allergan To Help Sell Map Pharma's Migraine Treatment
01/31/201109:09:31Allergan To Pay Map Pharma $60 Million To Co-Promote Levadex
06/23/201007:55:06Map Pharmaceuticals Sees Positive Study Results For Migraine...

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