Drug firm Zydus Cadila has received tentative approval from the the US Food and Drug Administration (USFDA) to market Osimertinib tablets, used to treat lung cancer.
The company has received tentative approval from the US health regulator to market Osimertinib tablets in the strengths of 40 mg and 80 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.
Osimertinib is used to treat lung cancer. Osimertinib works by slowing or stopping the growth of cancer cells.
The company said the newly approved medication will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
The group now has 318 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in the financial year 2003-04.
Recently, a study published in the BMC Pulmonary Medicine, revealed that patients with T790M-positive, non-small-cell lung cancer (NSCLC) and multiple central nervous system (CNS) metastases after failure of initial epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment, osimertinib (OSI) may be associated with significantly improved survival benefit.