US Food & Drug Administration grants Zydus Cadila tentative approval to market cancer drug

INDIA – Zydus Cadila has received tentative approval from the United States Food and Drug Administration (USFDA) to market Ibrutinib tablets used in the treatment of certain types of cancers. The company will market Ibrutinib tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg in the US though it will be manufactured at the group’s formulation manufacturing facility at Ahmedabad. Zydus Cadila now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process.…

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