Princeton, New Jersey, May 22, 2013 – Sandoz today announced the US Food and Drug Administration (FDA) approval and US launch of candesartan cilexetil tablets, the first generic version of ATACAND®.
Candesartan cilexetil tablets are indicated to treat some types of heart failure in adults with left ventricular systolic dysfunction, and hypertension in adults and children 1 to 17 years of age. They may be used alone or in combination with other antihypertensive agents.1
Hypertension is a condition that affects nearly 30 percent of all adults aged 18 and older in the US.2
“Sandoz is proud to be the first generic company to market this important generic treatment option to patients in the US,” said Don DeGolyer, President of Sandoz US. “The launch of candesartan further expands our offering of high-quality, affordable cardiology medicines.”
Sandoz is marketing candesartan cilexetil tablets in 4 mg, 8 mg, 16 mg, and 32 mg strength tablets, which are the same strengths marketed for ATACAND®.
According to IMS Health, US sales for branded candesartan cilexetil tablets were USD 120.3 million for calendar year 2012.
The foregoing release contains forward-looking statements that can be identified by terminology such as “launches,” or similar expressions, or by express or implied discussions regarding potential future revenues from candesartan tablets. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that candesartan tablets will achieve any particular levels of revenue in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including potential FDA approval of additional generic versions of candesartan tablets; unexpected product manufacturing difficulties; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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 the Novartis group, is the second-largest generic pharmaceuticals company globally, offering a broad range of about 1,000 high-quality, affordable products that are no longer protected by patents. With approximately 25,000 employees in 140 countries, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology, and antibiotics. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In 2012, Sandoz posted sales of USD 8.7 billion.