FDA rejects Multiple Sclerosis drug Cladribine application
FDA rejects Multiple Sclerosis drug Cladribine application
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
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.
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