FDA Rejects New Cladribine Indication

30 November 2009 (Last Updated November 30th, 2009 18:30)

The US Food and Drug Administration (FDA) has rejected a New Drug Application (NDA) from Merck Serono for a new indication of a therapy for relapsing forms of multiple sclerosis (MS). The FDA rejected the NDA on the basis that not enough information was submitted by Merck Serono, a divisi

The US Food and Drug Administration (FDA) has rejected a New Drug Application (NDA) from Merck Serono for a new indication of a therapy for relapsing forms of multiple sclerosis (MS).

The FDA rejected the NDA on the basis that not enough information was submitted by Merck Serono, a division of Merck KGaA, within the allotted 60 days to allow for a substantive review.

Merck Serono has announced that it will meet with the FDA as soon as possible to discuss its comments and to reach an understanding on what would be required for the Cladribine Tablets NDA to be accepted for review.

The oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of MS.