Zydus Cadila gets USFDA nod to market Allopurinol tablets
New Delhi: Drug firm Zydus Cadila on Saturday said it has received final approval from the US health regulator to market Allopurinol tablets used for the treatment of patients with gout and other conditions associated with too much uric acid and serum in the body.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Allopurinol tablets USP in the strengths of 100mg and 300 mg, Zydus Cadila said in a filing to the BSE.
The product will be manufactured at the group’s formulations manufacturing facility at Baddi, it added.
“The drug is indicated for the management of patients with gout and patients with cancer who are receiving therapy that causes elevations of serum and urinary uric acids,” Zydus Cadila said.
The group has more than 160 approvals and so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.