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
FDA rejects Multiple Sclerosis drug Cladribine application
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.
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.
-
- Similar Topics
- Replies
- Views
- Last post
-
- 0 Replies
- 1858 Views
-
Last post by frodo
-
- 1 Replies
- 1872 Views
-
Last post by frodo
-
- 0 Replies
- 1729 Views
-
Last post by frodo
-
- 0 Replies
- 1680 Views
-
Last post by frodo
-
- 0 Replies
- 1343 Views
-
Last post by frodo
-
- 0 Replies
- 1944 Views
-
Last post by NHE
-
- 0 Replies
- 2314 Views
-
Last post by frodo
-
- 0 Replies
- 3705 Views
-
Last post by frodo
-
- 0 Replies
- 1512 Views
-
Last post by frodo