Treats advanced or metastatic breast cancer. ANDA 217968, held by Teva Pharms USA Inc. Lapatinib Ditosylate.
As of Nov 15, 2026, ANDA 217968 (Lapatinib Ditosylate), held by Teva Pharms USA Inc, was first approved by FDA on Aug 16, 2024, with 0 approved supplements and 0 published complete response letters.
Lapatinib tablets are 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 capecitabine. 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 |
|---|---|---|---|
| Aug 16, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lapatinib DitosylateEQ 250MG BASE · tablet;oral | Lapatinib Ditosylate | Rx |
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
