Lupin launches Lapatinib tablets

Natco Pharma received final approval for its ANDA from USFDA

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Lupin
Photo by Amanda Jones on Unsplash

Pharma major 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.

According to IQVIA MAT June 2020, Lapatinib Tablets (RLD: Tykerb) had annual sales of approximately US$ 61 million in the US.

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