FDA approves manufacturing supplement for Orenitram tablets from UNITED THERAP
A CMC supplement for the oral extended-release drug Orenitram was approved, with an updated label posted.
This week's filing activity for UNITED THERAP centers on a single manufacturing update.
- A supplemental application (SUPPL 17) for Orenitram, an oral extended-release tablet containing treprostinil diolamine, was approved as a Manufacturing (CMC) submission under standard review priority.1 The sponsor is listed in FDA records as UNITED THERAP. The associated label document is dated 2026-08-04.1
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