Shilpa Medicare gets US FDA nod for Erlotinib tablets

Shilpa Medicare Ltd has received US Food and Drug Administration (FDA) final approval for its ANDA, Erlotinib tablets, 25 mg, 100 mg, and 150 mg. Erlotinib tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug Tarceva used in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) and locally advanced, unresectable or metastatic pancreatic cancer as recommended in the label approved by FDA. According to IQVIA MAT Q2 2019 data, the US market for Erlotinib tablets is approximately US$ 172 million.

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