Cladribine Approval Status
- FDA approved: No
- Generic name: cladribine
- Dosage form: Tablets
- Company: Merck & Co., Inc.
- Treatment for: Multiple Sclerosis
Cladribine (Tablets) is an investigational oral formulation of cladribine for reducing relapses in people with multiple sclerosis (MS).
In March 2011, Merck KGaA announced the receipt of a Complete Response Letter from the FDA, advising the company that the New Drug Application (NDA) for cladribine tablets had not been approved.
Development Status and FDA Approval Process for cladribine
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