Caraco Pharmaceutical Laboratories Ltd, announced that the US Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application (ANDA) for allopurinol tablets USP, 100 mg and 300 mg (Allopurinol). Allopurinol is indicated in the management of patients with signs and symptoms of primary or secondary gout, the management of patients with leukaemia, lymphoma and malignancies.
Who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion are elevated. Our generic Allopurinol is the bioequivalent to Zyloprim, a registered trademark of Prometheus Laboratories, Inc. According to IMS Data, for the twelve months ended June 2007, Allopurinol generic and brand products (Zyloprim) combined had annual sales of approximately $33 million.
Daniel H Movens, Caraco's CEO, 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. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 38 different products represented by 78 various strengths."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.