FDA clears first generics to treat high blood pressure
The FDA has approved the first generic versions of irbesartan (Avapro) and irbesartan/hydrochlorothiazide (Avalide) tablets for the treatment of high blood pressure.
"Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost," the FDA said. "These approvals are an important step in the agency’s efforts to increase the availability of generic medications." The brand name drugs, Avapro and Avalide, are marketed jointly by Bristol-Myers Squibb and Sanofi-Aventis.
Irbesartan is used alone or in combination with other medications, such as hydrochlorothiazide, to treat high blood pressure. It also is used to treat kidney disease in patients with type 2 diabetes and high blood pressure.
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, according to the FDA.
"Generic drugs approved by FDA have the same high quality and strength as brand name drugs," the agency stated. "The generic manufacturing and packaging sites must pass the same quality standards as those of brand name drugs."
Teva Pharmaceuticals of Jerusalem will manufacture generic irbesartan and irbesartan/hydrochlorthiazide. Teva has been awarded a 180-day period of marketing exclusivity.
According to the Centers for Disease Control and Prevention, approximately 76.4 million people age 20 and older have high blood pressure in the U.S. About one in two U.S. adults with high blood pressure have it under control.
"Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost," the FDA said. "These approvals are an important step in the agency’s efforts to increase the availability of generic medications." The brand name drugs, Avapro and Avalide, are marketed jointly by Bristol-Myers Squibb and Sanofi-Aventis.
Irbesartan is used alone or in combination with other medications, such as hydrochlorothiazide, to treat high blood pressure. It also is used to treat kidney disease in patients with type 2 diabetes and high blood pressure.
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, according to the FDA.
"Generic drugs approved by FDA have the same high quality and strength as brand name drugs," the agency stated. "The generic manufacturing and packaging sites must pass the same quality standards as those of brand name drugs."
Teva Pharmaceuticals of Jerusalem will manufacture generic irbesartan and irbesartan/hydrochlorthiazide. Teva has been awarded a 180-day period of marketing exclusivity.
According to the Centers for Disease Control and Prevention, approximately 76.4 million people age 20 and older have high blood pressure in the U.S. About one in two U.S. adults with high blood pressure have it under control.