Avalide


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Avalide®

Cardiology A tablet containing irbesartan/Avapro®, an angiotensin II receptor blocker, and hydrochlorothiazide, a thiazide diuretic for hypertensive Pts whose BP is poorly controlled by either agent as a monotherapy See Hypertension.
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Bristol-Myers Squibb reported worldwide sales of Avalide and Avapro of $307 million for the first half of 2010, which was down 2% from the 2009 period.
The product, marketed as Avalide by Bristol-Myers Squibb (BMS), was approved in 1997 for treating hypertension, with a statement in its label that says the combination therapy should not be used until a patient has failed to achieve the desired effect with monotherapy.
The first, a pivotal trial of 695 patients (mean age 52 years) with severe hypertension (an untreated diastolic blood pressure of at least 110 mm Hg or on monotherapy with a diastolic blood pressure of at least 100 mm Hg), compared Avalide with irbesartan monotherapy as initial therapy.
In the pivotal trial, 47% of patients on Avalide had achieved a diastolic blood pressure below 90 mm Hg at 5 weeks, the primary end point, compared with 33% of patients on irbesartan monotherapy, which was a highly significant difference.
Among black subjects (about 14% of the subjects), 40% of those on Avalide had achieved a diastolic blood pressure below 90 mm Hg at 5 weeks, compared with nearly 15% of those on irbesartan.
Overall, Avalide was safe and well tolerated, and was comparable to irbesartan, with no increase in dizziness or syncope and no serious adverse events related to treatment.
NYSE: TEVA) was the first to receive approval for Avapro and Avalide in April 2012 and enjoyed a 180-day period of marketing exclusivity.
Other key launches include the generic versions of Zyprexa (April 2012), Plavix (May 2012), Viramune (May 2012) Clarinex (July 2012) Singulair and Singulair Chew (August 2012), Avapro and Avalide (September 2012) and Atacand (December 2012).
7% and impacted notably by a voluntary recall of certain lots of Avalide (irbesartan-hydrochlorothiazide) by Bristol-Myers Squibb and sanofi-aventis from the U.
5% at constant exchange rates and included increase contribution of Plavix and the impact of the shortage of Avalide.
8% and impacted notably by a voluntarily recall of certain lots of Avalide (irbesartan-hydrochlorothiazide) by Bristol-Myers Squibb and sanofi-aventis from the U.