Sandoz launches authorized generic version of EXFORGE® in the US
Mar 31, 2015
Princeton, New Jersey, March 31, 2015 – Sandoz today announced the US market introduction of amlodipine and valsartan combination tablets, a generic version of EXFORGE® made by Novartis.
Amlodipine and valsartan tablets are a combination of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB).
Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure:
in patients not adequately controlled on monotherapy with a DHP CCB or an ARB
as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
“We are pleased to add amlodipine and valsartan combination tablets to our portfolio of antihypertensive medicines,” said Peter Goldschmidt, President of Sandoz Inc. “We believe it is important to provide a high-quality and affordable alternative to the millions of Americans affected by hypertension.”
According to IMS Health, US sales for the branded version of amlodipine and valsartan tablets were approximately USD 329 million for the 12 months ending in January 2015. Sandoz will market amlodipine and valsartan tablets in 5-160mg, 5-320mg, 10-160mg, 10-320mg strength tablets, the same strengths as the brand.
Important Safety Information
See full prescribing information for complete boxed warning
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue amlodipine as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Serious side effects could occur with EXFORGE, such as:
Low blood pressure (hypotension)
Worsening of chest pain (angina) or heart attack, particularly in patients who already have severe heart disease
Changes in blood test results in people with congestive heart failure
The most common side effects that occur more frequently with EXFORGE than placebo (sugar pill) are swelling of the hands, ankles, or feet; nasal congestion or sore throat’ head or chest cold; and dizziness.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “will,” or similar terms, or by express or implied discussionsregarding potential revenues from amlodipine and valsartan tablets. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that amlodipine and valsartan tablets will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of amlodipine and valsartan tablets; national trends toward health care cost containment, including ongoing pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. Sandoz also holds leading global positions in key therapeutic areas ranging from generic injectables, dermatology and respiratory to cardiovascular, metabolism, central nervous system, pain and gastrointestinal.
Sandoz develops, produces and markets finished dosage form (FDF) medicines as well as intermediary products including active pharmaceutical ingredients (APIs) and biotechnological substances. Nearly half of the Sandoz portfolio is in differentiated products – medicines that are scientifically more difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and Fougera Pharmaceuticals (US).