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FDA Approves New Lotrel (Amlodipine Besylate/Benazepril HCl) Dosage Strengths

Lotrel Now Provides More Flexible Dosing for Managing High Blood Pressure

EAST HANOVER, N.J. -- June 9, 2006 -- Novartis Pharmaceuticals Corporation announced it has received marketing approval from the U.S. Food and Drug Administration (FDA) for two new dosing strengths of Lotrel (R) (amlodipine besylate/benazepril HCl), 5/40 mg and 10/40 mg.

The new dosing strengths combine the calcium channel blocker (CCB) amlodipine with the highest available dose of the ACE inhibitor benazepril.

Lotrel has the broadest marketed dosing range of any CCB and ACE inhibitor combination. Lotrel has proven efficacy and tolerability and is one of the fastest growing branded antihypertensives on the market with sales exceeding a billion dollars in 2005.

The addition of the new higher strengths provides physicians with expanded dosing flexibility and offers two additional treatment options for previously uncontrolled patients who need powerful blood pressure lowering with the benefits of the higher dose ACE inhibitor.

"Lotrel 5/40 mg and 10/40 mg offer physicians powerful new options to manage high blood pressure effectively, conveniently and efficiently with the highest available dose of an ACE inhibitor," said Marjorie Gatlin, MD, Vice President CVM, Novartis Pharmaceuticals Corporation. "Bringing to market additional doses of Lotrel demonstrates Novartis' continuing commitment to improving the care of patients with hypertension."

Both new Lotrel strengths contain a higher dose of the ACE inhibitor benazepril, compared with other Lotrel doses. Lotrel 5/40 mg contains 5 mg of amlodipine besylate and 40 mg of benazepril HCl, and the 10/40 mg contains 10 mg of amlodipine besylate and 40 mg of benazepril. The additional 5/40 mg and 10/40 mg doses of Lotrel will be available in June 2006, after which Lotrel will be marketed in six dosage strengths -- 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, 10/40 mg.

Novartis continues to explore Lotrel's clinical potential in the landmark large-scale clinical trial ACCOMPLISH, which is designed to determine if Lotrel is more effective at preventing cardiovascular disease and death than an ACE/diuretic combination. Results are expected in 2009.

About High Blood Pressure
More than 65 million Americans have high blood pressure. However, nearly 70 percent of these do not have their blood pressure controlled to the recommended level of less than 140/90 mm Hg. National guidelines recommend most patients will require a combination of medications to lower their blood pressure to goal.

Important Considerations
Lotrel should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child. If you get pregnant or plan to get pregnant, call your doctor right away.

Do not take Lotrel if you are allergic to any of the ingredients in this product, or to any ACE inhibitor.

In rare cases with Lotrel, a potentially dangerous swelling of the mouth and throat can occur. Rarely, worsening chest pain (angina) or heart attack has been reported, particularly in patients who already have severe heart disease. Serious side effects such as low blood pressure (hypotension) and kidney problems could occur. The most common side effects include cough, headache, edema (swelling of the feet, ankles, legs, or hands) and dizziness.

Lotrel is not indicated for the initial treatment of high blood pressure. Lotrel may be the right medication for you if certain other blood pressure medicines have not worked or have caused too much swelling.


SOURCE: Novartis Pharmaceuticals Corporation

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