Parent company: Merck Serono, Inc.

The FDA gave Fast Track approval status to cladribine in July 2006. In March 2011, the FDA announced that it would not approve oral cladribine for MS without more safety information. In June 2011, Merck Serono announced that they will not currently pursue global approval for Cladribine Tablets for the treatment of RRMS, but would continue existing clinical trials. The company may consider a reapplication if safety concerns are lessened.