Lupin Receives Tentative US FDA Approval for its TALZENNA Tablets
Mumbai, Maharashtra, India - 30 March 2023:
Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its TALZENNA® (talazoparib) tablets, 0.25 mg and 1 mg, under the President's Emergency Plan for AIDS Relief (PEPFAR).
TALZENNA is indicated for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received prior therapy with trastuzumab and a taxane. The tentative approval is subject to final review and issuance of a final approval letter from the US FDA.
Lupin's TALZENNA is a generic version of Pfizer's TALZENNA tablets, 0.25 mg and 1 mg. TALZENNA had annual sales of approximately USD 1.07 billion in the United States according to IQVIA MAT December 2022.
Shares of Lupin Limited were trading 1.34% higher at Rs 877.90 on BSE.
Komentar