Treats breast cancer after failure of combination chemotherapy for metastatic disease or…. NDA 211875, held by Am Regent. Paclitaxel.
As of Nov 13, 2026, NDA 211875 (Paclitaxel), held by Am Regent, was first approved by FDA on Jul 27, 2022, with 0 approved supplements and 0 published complete response letters.
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paclitaxel100MG/VIAL · powder;intravenous | Paclitaxel | 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
