Prevents organ rejection. ANDA 205775, held by Ph Health. Everolimus.
As of Nov 13, 2026, ANDA 205775 (Everolimus), held by Ph Health, was first approved by FDA on Oct 18, 2021, with 0 approved supplements and 0 published complete response letters.
Everolimus is a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5 ) Limitations of Use: Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk. Recipients of transplanted organs other than kidney or liver. ( 1.3, 5.7 ) Pediatric patients (less than 18 years). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Everolimus0.25MG · tablet;oral | Everolimus | Discontinued |
| Everolimus0.5MG · tablet;oral | Everolimus | Discontinued |
| Everolimus0.75MG · tablet;oral | Everolimus | Discontinued |
| Everolimus1MG · tablet;oral | Everolimus | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
