FDA accepts resubmision of NDA for cladribine tablets as a treatment for relapsing forms of multiple sclerosis . Merck KGaA.

Merck, a leading science and technology company announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) has been accepted for filing by the FDA . The acceptance indicates that the FDA has found the company�s resubmission sufficiently complete to permit a substantive review. The resubmission is in response to the Complete Response Letter issued by the FDA in 2011 requesting an improved understanding of safety risks and the overall benefit-risk profile. The NDA acceptance follows global approvals of cladribine tablets under the trade name Mavenclad� in 38 countries since August 2017, including the European Union (EU), Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon. Additional filings in other countries are planned for 2018.