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Search Orphan Drug Designations and Approvals: FDA Home Developing Products For Rare Diseases & Conditions by gopalkarva is a document available to read on EtoBox.
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The document provides information on the orphan drug designation and approval for lenvatinib, marketed as LENVIMA, which is used for the treatment of unresectable hepatocellular carcinoma. It was designated on March 27, 2014, and received marketing approval on August 15, 2018, with exclusivity until August 15, 2025. The sponsor of the drug is Eisai Inc., located in Nutley, New Jersey.
- Author
- gopalkarva
- Language
- EN