Zydus Lifesciences Gets U.S. FDA Nod For Chemotherapy Drug
Zydus Lifesciences has received final approval to market Pemetrexed injection used to treat certain types of cancers.
Zydus Lifesciences Ltd. on Thursday said it has received final approval from the U.S. health regulator to market Pemetrexed injection used to treat certain types of cancers.
The approval granted by the U.S. Food and Drug Administration is for Pemetrexed for injection, in strengths of 100 mg/vial, 500 mg/vial, and 1,000 mg/vial of single dose, the company said in a regulatory filing.
Pemetrexed is used to treat certain types of cancers such as lung cancer and mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells, it added.
The drug will be manufactured at Zydus Hospira, Gujarat, the company said.
Citing IQVIA MAT March 2022 data, the company said Pemetrexed for injection had a market size of $1.23 billion. The group now has 314 approvals and has filed over 400 abbreviated new drug applications since the commencement of the filing process in 2003-04.