NDA 215331, held by Maia Pharms Inc. Bortezomib.
As of Nov 13, 2026, NDA 215331 (Bortezomib), held by Maia Pharms Inc, was first approved by FDA on Jul 27, 2022, with 0 approved supplements and 0 published complete response letters.
Bortezomib injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma treatment of adult patients with mantle cell lymphoma 1.1 Multiple Myeloma Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bortezomib3.5MG/3.5ML (1MG/ML) · solution;intravenous | Bortezomib | DiscontinuedReference drug |
| Bortezomib3.5MG/1.4ML (2.5MG/ML) · solution;intravenous | Bortezomib | DiscontinuedReference 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
