Caraco gets final FDA approval for Allopurinol

DETROIT The Food and Drug Administration has granted final approval on an application by Caraco Pharmaceuticals for Allopurinol 100 and 300 mg tablets.

Allopurinol, the generic equivalent of Prometheus' Zyloprim, is used in the management of patients with signs and symptoms of primary and secondary gout, as well as in the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy.

Daniel H. Movens, Caraco’s chief executive officer, said, "We are pleased to gain this approval from the FDA. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value.

Brand and generic Allopurinol had combined sales of about $33 million last year, according to IMS Health data.