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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-74/
- Published: 2018-08-26T12:00:00.000Z
- Updated: 2026-09-15T00:28:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142046

**DEVICES**

FDA has approved **Medtronic**’s Implantable System for Remodulin for treating patients with pulmonary arterial hypertension (PAH). The device/drug collaboration leverages Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies to deliver **United Therapeutics**’ Remodulin (treprostinil) injection. United Therapeutics will lead the product’s promotion with Medtronic’s support, the companies say.

FDA has approved an **Integer Holdings** PMA for its radial access introducer RadialSeal. The device was designed using the company’s guidewires and hemostatic introducers. The company says it has optimal treatment flexibility provided by a thin walled sheath design that minimizes outer diameter while maximizing inner diameter, and ease of sheath insertion through smooth transitions and hydrophilic coats. It is intended for use in interventional cardiology and peripheral vascular procedures.

**DRUGS**

FDA has approved an **Indivior** NDA for Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for treating schizophrenia in adults. Approval was based on data showing that clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental oral risperidone. The monthly dosing addresses treatment adherence, which is a major challenge in schizophrenia due to the disease complexity.

FDA has approved a **Shionogi** NDA for Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist for treating thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Approval was based on safety and efficacy data from two Phase 3 clinical trials, L-PLUS 1 and L-PLUS 2, in which Mulpleta met primary and secondary endpoints, the company says.