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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  a modified version of methionine gamma-lyase (MGL) enzyme from the bacterium Pseudomonas entomophila
Date Designated:  01/18/2022
Orphan Designation:  Treatment of homocystinuria
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Codexis, Inc.
200 Penobscot Drive
Redwood City, California 94063
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.