Ivax Corporation has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for anagrelide HCl capsules in 0.5 and 1 mg dosage strengths. This product will be sold through Ivax' wholly owned subsidiary, Ivax Pharmaceuticals, Inc.
Anagrelide HCl capsules is the generic equivalent of Agrylin Capsules, which is marketed by Shire US, Inc. for thrombocythemia, a condition in which there are too many platelets in the blood, resulting in bleeding, blood clots, enlarged spleen, or stroke. According to IMS data, US sales of anagrelide HCl capsules, 0.5 and 1 mg, were $105 million during 2004.