This article is more than 5 years old. Information may no longer be current.

FDA approves generic irbesartan

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA today announced its approval of the first generic versions of irbesartan and combination irbesartan-hydrochlorothiazide tablets for treatment of high BP.

Generic irbesartan (Avapro, Sanofi-Aventis) and irbesartan-hydrochlorothiazide (Avalide, Sanofi-Aventis) will include all safety information, including a boxed warning for women who are pregnant or may become pregnant.

Teva Pharmaceuticals will manufacture generic irbesartan and irbesartan-hydrochlorothiazide.

Irbesartan and combination irbesartan-hydrochlorothiazide block 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. The drug is also used to treat kidney disease in patients with type 2 diabetes and high BP.