The FDA's REMS website, REMS@FDA, has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
2. Myalept (metreleptin) REMS modified 12/11 to revise prescriber training materials to highlight the risk of developing severe infections and the availability of testing for anti-metreleptin neutralizing antibodies if severe infections occur, and and the addition of a new communication plan which includes a new REMS letter to currently certified prescribers to inform them of the availability of updated training materials.
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