Treats thrombocytopenia. NDA 210923, held by Vancocin Italia. Lusutrombopag.
As of Nov 13, 2026, NDA 210923 (Mulpleta), held by Vancocin Italia, was first approved by FDA on Jul 31, 2018, with 0 approved supplements and 0 published complete response letters.
MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mulpleta3MG · tablet;oral | Lusutrombopag | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
