Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Erlotinib tablets used in the treatment of cancer.
The approved product is therapeutically equivalent to the reference listed drug product Tarceva tablets of OSI Pharmaceuticals, LLC.
The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Erlotinib tablets in the strengths of 25 mg, 100 mg, and 150 mg, Alembic Pharmaceuticals said in a regulatory filing.
Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC). The tablet in combination with gemcitabine is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Quoting IQVIA data, Erlotinib tablets have an estimated market size of $37 million for the twelve months ending March 2021.
Alembic has a cumulative total of 148 ANDA approvals (130 final approvals and 18 tentative approvals) from the USFDA