Singapore (CU)_ The Abbreviated New Drug Application (ANDA) for erlotinib tablets, 25 mg, 100 mg, and 150 mg secured the final approval from the US Food and Drug Administration. The authorized ANDA is therapeutically similar to the reference listed drug product (RLD), Tarceva tablets, 25 mg, 100 mg, and 150 mg of OSI Pharmaceuticals.
Metastatic non-small cell lung cancer (NSCLC) patients, whose tumors contain epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as identified by an FDA-authorized test, and who are receiving first-line, maintenance, or second or greater line treatment after progression following minimum of one prior chemotherapy treatment are
eligible to receive the drug.
Patients with locally advanced, unresectable, or metastatic pancreatic cancer should get erlotinib tablets together with gemcitabine as a first-line treatment. According to IQVIA statistics, the expected market size of Erlotinib tablets, 25 mg, 100 mg, and 150 mg, is $37 million for the past twelve months as of March 2021.
Moreover, Alembic Pharmaceuticals has received 148 ANDA approvals in total from the USFDA, which includes 130 final approvals and 18 uncertain approvals. The statement was made on July 9, 2021, during market hours. Alembic Pharmaceuticals’ net profit increased 16.7% to INR 237.41 crore in Q4 FY21 compared to Q4 FY20, which is a 6.1 percent increase in net sales to INR 1,280.39 crore.
Alembic Pharmaceuticals is a vertically integrated pharmaceutical research and development firm. It produces and distributes generic pharmaceutical goods globally. In 2016, Alembic Pharmaceuticals was named to Forbes’ list of “India’s Super 50 Companies 2016”, and in 2015, it was named one of Thomson Reuters’ Top 50 Indian Innovators.
