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FDA rejects Multiple Sclerosis drug Cladribine application
Posted: Mon Nov 30, 2009 8:09 am
FDA rejects Multiple Sclerosis drug Cladribine application as 'incomplete'
U.S. regulators rejected as incomplete Merck KGaA's application to sell the oral treatment multiple sclerosis. Merck, the German based drugmaker will seek a meeting with the U.S. Food and Drug Administration after the agency refused to accept i...ts application for the medicine, cladribine, spokesman Gangolf Schrimpf said.......
More - http://www.msrc.co.uk/index.cfm?fuseact ... ageid=1629
Posted: Mon Nov 30, 2009 9:18 am
Bummer. I hope it doesn't take them too long to sort it out.
I also hope Novartis does better with their app for Fingolimod. Novartis said they had been in contact with the FDA throughout the later stages of the trial, so I hope their application is complete and doesn't delay the review. They're supposed to file before the end of this year.