FDA approves first Avapro/Avalide generics to treat high blood pressure, kidney disease
[ 4-2-2012] On March 30, 2012, the U.S. Food and Drug Administration approved the first generic versions of Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide) tablets for the treatment of high blood pressure.
Generic drugs provide safe and effective alternatives to brand-name drugs, usually at a lower cost. These approvals are an important step in the agency’s efforts to increase the availability of generic medications.
Irbesartan is used alone or in combination with other medications, such as hydrochlorothiazide, to treat high blood pressure. It is also used to treat kidney disease in patients with type 2 diabetes and high blood pressure.
High blood pressure is a major risk factor for heart disease, stroke, congestive heart failure, and kidney disease.
The drug works by blocking the action of certain natural substances that constrict the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
According to the Centers for Disease Control and Prevention, about 76.4 million people age 20 and older have high blood pressure in the United States. About 1 in 2 U.S. adults with high blood pressure have it under control.
Generic irbesartan and irbesartan and hydrochlorothiazide will include all current safety information, including a boxed warning for female patients who are pregnant or may become pregnant.
Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Teva Pharmaceuticals, Inc will manufacture generic irbesartan, and irbesartan and hydrochlorthiazide, Contact the manufacturer about the availability of these products.