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Mavenclad Approval History

FDA Approved: Yes (First approved March 29, 2019)
Brand name: Mavenclad
Generic name: cladribine
Dosage form: Tablets
Company: EMD Serono, Inc.
Treatment for: Multiple Sclerosis

Mavenclad (cladribine) is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Development History and FDA Approval Process for Mavenclad

DateArticle
Mar 29, 2019Approval FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis
Jul 30, 2018FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis
Jun 22, 2011Merck: Regulatory Update on Cladribine Tablets
Mar  2, 2011Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Application
Nov 29, 2010Merck KGaA Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of MS
Jul 28, 2010FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis
Jun  8, 2010Merck Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy
Apr 16, 2010New Data Supporting Cladribine Tablets as a Potential New Therapeutic Option Presented at the 62nd AAN Annual Meeting
Jan 21, 2010Two-Year Results From CLARITY Study with Cladribine Tablets in Multiple Sclerosis Published in The New England Journal of Medicine
Nov 30, 2009Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application
Oct  2, 2009Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States
Sep 11, 2009New Data From CLARITY Study on Disease Activity in MS Patients Who Received Cladribine Tablets Presented at 25th ECTRIMS Congress
Jun 25, 2009New Data from CLARITY Study Presented at 19th ENS Meeting Show Rapid and Sustained MS Relapse Reduction for Cladribine Tablets
Apr 30, 2009Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients with Multiple Sclerosis
Jan 23, 2009Oral Investigational Treatment Cladribine Tablets for Multiple Sclerosis Significantly Reduced Relapse Rate in Phase III Pivotal Trial

Further information

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