Erlotinib is a generic equivalent of reference listed drug (RLD) Tarceva.
Shares of Shilpa Medicare gained five percent on November 6 after the US health regulator approved a drug that is used for treating lung and pancreatic cancer.
The pharma company informed exchanges that it has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA), Erlotinib tablets on November 5. The drug is available in 25 mg, 100 mg, and 150 mg strengths.
Erlotinib is a generic equivalent of reference listed drug (RLD) Tarceva. The drug is 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 $172 million, the company said in a statement.