Zydus Cadila Gets Tentative US Regulator Nod for Cancer Drug


New Delhi: Drug firm Zydus Cadila has received tentative approval from the US Food and Drug Administration (FDA) to market Clofarabine injection, used for treatment of cancer of the white blood cells, in the American market.

“Zydus Cadila has received the tentative approval from the United States Food and Drug Administration (US health regulator) to market Clofarabine injection 20mg/20ml vials,” Cadila Healthcare said in a filing to the BSE.

The group now has more than 100 approvals and has filed over 280 abbreviated new drug applications (ANDAs) since the commencement of the filing process in fiscal 2003-04, it added.

Clofarabine is used to treat acute lymphoblastic leukemia (a type of cancer of the white blood cells) of 1-21 years old pediatric patients.

Shares in Cadila Healthcare, on Wednesday, ended 2.56 per cent higher at Rs 344.10 apiece on the BSE, whose benchmark Sensex index finished up 0.55 per cent.