Lupin announced the launch of Lapatinib Tablets, 250 mg, after Lupin's alliance partner Natco Pharma received final approval for its ANDA from the United States Food and Drug Administration (USFDA).
Lapatinib Tablets, 250 mg, are the generic equivalent of Tykerb® Tablets, 250 mg, of Novartis Pharmaceutical Corporation, and 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
- 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
Lapatinib Tablets (RLD: Tykerb®) had annual sales of approximately USD 61 million in the U.S. (IQVIA MAT June 2020).