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.
At the meeting on Avalide, BMS provided the results of two studies.
Pharmaceutical company Mylan Inc (NasdaqGS:MYL) reported on Friday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Irbesartan Tablets USP, 75mg, 150mg and 300mg, the generic version of Sanofi's Avalide.
Concurrently, the company has been awarded final approval from the FDA for its ANDA for Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5mg, the generic version of Sanofi's Avalide.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
According to the company, it has even received final FDA approval for its ANDA for Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, the generic version of Sanofi's Avalide.
Teva's recent generic drug introductions (brand equivalent in parentheses) include clopidogrel tablets USP (Plavix), escitalopram tablets USP (Lexapro), fluvastatin capsules USP (Lescol), irbesartan and hydrochlorothiazide tablets USP (Avalide), irbesartan tablets USP (Avapro), methotrexate injection USP (N/A), methylphenidate hydrochloride extended-release capsules LA (Ritalin LA), montelukast sodium chewable tablets (Singulair), montelukast sodium tablets (Singulair), olanzapine and fluoxetine capsules USP (Symbyax), oxaliplatin injection (Eloxatin), quetiapine fumarate tablets (Seroquel), voriconazole tablets (Vfend).
M2 PHARMA-April 2, 2012-Teva launches generic Avapro and generic Avalide in the US(C)2012 M2 COMMUNICATIONS
Next year, Maciw noted, an even larger number of key products, including Nexium, Diovan/ HCT, Avapro, Atacand, Singulair, Avalide, Nasonex, Avandia, Reminyl ER, Taxatore, Strattera, and Zomig/R will all come off patent, representing some $2.3 billion in sales.
patent expirations for Avapro/ Avalide (down 56% to $95 million) and Plavix (down 96% to $64 million).