FDA Approves 2 Generic High Blood Pressure Medications

The FDA recently approved 2 Teva Pharmaceutical generic drugs for use in patients with hypertension.

Teva Pharmaceuticals recently announced the approval of the generic version of Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) tablets. The generic is in the final stages before its launch in the US.

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is a combination treatment of an angiotensin II receptor blocker, a dihydropyridine calcium channel blocker, and a thiazide diuretic, according to a press release from Teva. The drug is indicated to lower blood pressure in patients with hypertension.

The generic drug can be used as a monotherapy, or in combination with other anti-hypertensive drugs. Many patients will need to use this product in combination with other drugs to lower their blood pressure enough to lower associated risks.

Common adverse reactions to olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets include dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling.

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are not for use as a first-line therapy for hypertension, Teva reported.

Teva also recently announced the FDA approval and launch of generic Azor (amlodipine and olmesartan medoxomil) tablets, which are a dihyropyridine calcium channel blocker and angiotensin II receptor blocker, which is also indicated to lower blood pressure in patients with hypertension.

Amlodipine and olmesartan medoxomil tablets can be used as initial treatment for these patients, according to Teva. Like the other recently approved generic, this drug can be used as a monotherapy or in combination with other treatments. The most common adverse reaction seen in clinical trials was edema.

Lowering blood pressure can lessen the risk of certain serious cardiovascular events, such as strokes and myocardial infarctions. A decreased risk in these events has been seen in clinical trials of anti-hypertensive drugs, but there have not been any controlled trials that examine the risk reduction with both of these generics.

Controlling blood pressure should be part of a plan for managing cardiovascular risks that includes lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium consumption, according to Teva.

Tirbenzor had sales of $240 million in the United States, and Azor has sales of $354.1 million, as reported by IMS Health in 2016. In the United States, 1 in 6 generics dispensed is with a Teva drug.

These latest approvals add 2 more generic anti-hypertensive drugs to their expansive generics profile, Teva concluded.