Zydus gets USFDA nod for chemotherapy drug

The approval granted by the US Food and Drug Administration (USFDA) 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.

zydus lifesciences
Pemetrexed is used to treat certain types of cancers such as lung cancer, mesotheliom.

Zydus Lifesciences on Thursday said it has received final approval from the US health regulator to market Pemetrexed for injection used to treat certain types of cancers. The approval granted by the US Food and Drug Administration (USFDA) 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, 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 USD 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.

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