Princeton, New Jersey, July 8, 2014 - Sandoz today announced the US introduction of an authorized generic version of Diovan® (valsartan) tablets for the treatment of high blood pressure (HBP).
This launch follows the Sandoz US introduction of an authorized generic version of Diovan HCT® (valsartan and hydrochlorothiazide) in 2012. Both Diovan and Diovan HCT are marketed in the US by Novartis Pharmaceuticals Corporation (NPC) and are indicated for the treatment of HBP, a condition that affects approximately one in three US adults.1,2
“We are pleased to offer authorized generic versions of these leading anti-hypertensive medicines, which together represent the number one prescribed branded ARB* medicine in the US,” said Peter Goldschmidt, President of Sandoz Inc. “This important partnership with our colleagues at NPC is further evidence of the key role played by Sandoz and Novartis in increasing patient access to high-quality healthcare.”
US net sales for Diovan and Diovan HCT in 2013 were approximately USD 1.7 billion. Sandoz will market the authorized generic version of Diovan in 40mg, 80mg, 160mg, and 320mg strength tablets, the same strengths marketed for the branded version of Diovan.
Important Safety Information for Valsartan Tablets and Valsartan and Hydrochlorothiazide Tablets
Warning: Valsartan and valsartan and hydrochlorothiazide can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking valsartan or valsartan and hydrochlorothiazide, tell your doctor right away.
See full Prescribing Information for complete Boxed WARNING.
Do not take valsartan and hydrochlorothiazide if you have low or no urine output (anuria), or if you have allergic reactions to certain drugs known as sulfonamides.
Serious side effects may occur with valsartan and valsartan and hydrochlorothiazide, such as:
Low blood pressure (hypotension), especially if you take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy and call your doctor right away.
Kidney problems. Call your doctor if you have swelling in your feet, ankles, or hands or have unexplained weight gain.
Serious side effects may occur with valsartan and hydrochlorothiazide, such as:
Skin rash. Call your doctor right away if you get an unusual rash.
Eye problems. Call your doctor right away if you have eye pain or decrease in vision.
Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant, have any allergies, have a heart condition, have liver or kidney problems, have or have had gallstones, have lupus, or are breast-feeding. Valsartan or valsartan and hydrochlorothiazide may pass into your breast milk and can harm your baby. You should not take valsartan or valsartan and hydrochlorothiazide and breast-feed. People with and without allergy problems or asthma who take valsartan and hydrochlorothiazide may get allergic reactions.
Tell your doctor about all the medicines you take. If you are taking valsartan or valsartan and hydrochlorothiazide, especially tell your doctor if you take other medicines for high blood pressure or a heart problem; water pills (diuretics); potassium supplements or a salt substitute containing potassium; or aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs, like ibuprofen or naproxen); diabetes medicine including insulin; narcotic pain medicines; sleeping pills; or lithium, a medicine used to treat some types of depression.
If you are taking valsartan and hydrochlorothiazide, tell your doctor if you develop any of the following signs of fluid and electrolyte problems: dry mouth, thirst, weakness, lack of energy, drowsiness, restlessness, confusion, seizures, muscle pain or cramps, muscle fatigue, low blood pressure, very low urine output, fast heartbeat, or nausea or vomiting.
The most common side effects seen with valsartan in people with high blood pressure are headache, dizziness, flu symptoms, tiredness, and stomach (abdominal) pain. The most common side effects of valsartan seen in people with heart failure are dizziness, low blood pressure, diarrhea, joint and back pain, tiredness, and high blood potassium.
Common side effects of valsartan used to treat people after a heart attack that caused them to stop taking the drug are low blood pressure, cough, high blood creatinine (decreased kidney function), and rash. The most common side effect with valsartan and hydrochlorothiazide is cold-like symptoms.
For further information, please see full Prescribing Information, including Boxed WARNING, for valsartan and valsartan and hydrochlorothiazide.
*ARB medicines are angiotensin receptor blockers, used to treat high blood pressure.
1Valsartan is a prescription medicine called an angiotensin receptor blocker (ARB). It is used in adults to: lower high blood pressure (hypertension) in adults and children, 6 to 16 years of age; treat heart failure in adults; and, improve the chance of living longer after a heart attack (myocardial infarction) in adults, however not all strengths are indicated for treatment of all of these conditions. For full safety information, please see the valsartan tablets prescribing information, available in the Product Catalog at www.us.sandoz.com.
The foregoing release contains forward-looking statements that can be identified by terminology such as “launches,” “introduction,” “launch,” or similar expressions, or by express or implied discussions regarding potential future revenues from generic or branded valsartan products. 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 generic or branded valsartan products 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 versions of Diovan® or Diovan HCT®; unexpected product development difficulties; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; 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, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically 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 benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).