Shilpa Medicare gets USFDA approval for generic equivalent of cancer drug TARCEVA

Erlotinib Tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug (RLD) TARCEVA used in the treatment of patients with metastatic non-small cell lung cancer.

New Delhi: Drug firm Shilpa Medicare recently said that the company has received U.S Food and Drug Administration 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 (RLD) 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.

Also Read: Shilpa Medicare gets USFDA nod for Irinotecan injection to treat cancer

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.

Also Read: Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer