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Mavenclad FDA 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 Timeline for Mavenclad

DateArticle
Mar 29, 2019ApprovalFDA 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
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

Further information

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