Treats advanced or metastatic breast cancer. ANDA 203007, held by Natco Pharma Ltd. Lapatinib Ditosylate.
As of Nov 15, 2026, ANDA 203007 (Lapatinib Ditosylate), held by Natco Pharma Ltd, was first approved by FDA on Sep 29, 2020, with 1 approved supplement and 0 published complete response letters.
Lapatinib tablets are kinase inhibitor indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with lapatinib tablets in combination with capecetabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lapatinib DitosylateEQ 250MG BASE · tablet;oral | Lapatinib Ditosylate | Rx |
| May 1, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 29, 2020 | Original application | Approved |
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
