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Anagrelide

Anagrelide (Agrylin®, Shire) is a drug used for the treatment of essential thrombocytosis (ET; essential thrombocythemia). It works by inhibiting the maturation of megakaryocytes into platelets. The exact mechanism of action is unclear, although it is known to be a potent (IC50 = 36nM) inhibitor of phosphodiesterase-III. more...

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In a 2005 head-to-head study (Harrison et al) hydroxyurea was found to be superior to anagrelide for the management of ET, with a small increase in the number of cases of myelofibrosis.

Side Effects

Headache, diarrhea, unusual weakness, nausea, dizziness may occur. If these persist or worsen, notify your doctor. Notify your doctor promptly if you develop: shortness of breath, swelling, stomach or chest pain, rash, itching, tingling sensations. Unlikely but report promptly: irregular or fast heartbeat, one-sided muscle weakness in arms or legs, black stools, fainting, mental changes, vision problems, unusual bleeding or bruising, pink-colored urine. Very unlikely but report promptly: unusual change in the amount of urine. If you notice other effects not listed above, contact your doctor or pharmacist.

Reference

  • Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med 2005;353:33-45. PMID 16000354.

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IVAX Receives Final FDA Approval for Anagrelide HCl Capsules
From Business Wire, 4/18/05

MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) has received final approval from the U.S. Food and Drug Administration (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(R) Capsules, which is marketed by Shire U.S., 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, U.S. sales of anagrelide HCl capsules, 0.5 and 1 mg, were $105 million during 2004.

IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.

Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' generic products, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of anagrelide HCl capsules in 0.5mg and 1mg strengths may be delayed; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Agrylin(R) is a registered trademark of Shire U.S., Inc.

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COPYRIGHT 2005 Gale Group

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