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www.fdanews.com/articles/97965-caraco-announces-fda-approval-to-market-generic-version-of-zyloprim

Caraco Announces FDA Approval to Market Generic Version of Zyloprim

September 4, 2007

Caraco Pharmaceutical Laboratories reported that the FDA has granted final approval for the company’s abbreviated new drug application for Allopurinol tablets, 100 and 300 mg.

Allopurinol is indicated in the management of patients with primary or secondary gout, leukemia, lymphoma and malignancies who are receiving cancer therapy that causes elevations of serum and urinary uric acid levels, as well as the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion are elevated.

Allopurinol is the bioequivalent to Prometheus’ Zyloprim.

According to IMS Data, for the 12-month period that ended in June, Allopurinol generic and brand products combined had annual sales of approximately $33 million.