FDA approves Yulzety, a new rivaroxaban oral suspension from Rosemont Pharms

The U.S. Food and Drug Administration approved Yulzety, an oral suspension formulation of rivaroxaban, under a new drug application filed by Rosemont Pharms. The application, NDA221033, was approved as a Type 3 submission for a new dosage form, with a submission status date of 2026-10-16.¹

The approval covers two strengths of the oral suspension. Yulzety is formulated as an oral route suspension containing rivaroxaban at strengths of 4MG/ML and 2MG/ML.¹

The FDA designated the review as standard priority rather than priority review. The review priority was listed as standard.¹

Regulatory documentation tied to the approval includes a product label and an approval letter. The label document is dated 20261020 and the approval letter is dated 20261021, both posted to the FDA's drug approval database.¹

No information in the available records addresses pricing, launch timing, or clinical trial data supporting the new formulation. Readers seeking those details should watch for additional company statements or FDA postings beyond the application record cited here.