Princeton, New Jersey, July 21, 2016– Sandoz today announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor® by AstraZeneca Pharmaceuticals LP1.
"The U.S. launch of rosuvastatin calcium is a strategic addition to the broad portfolio of generic medicines that Sandoz offers to improve cardiovascular health in adults,” said Peter Goldschmidt, President of Sandoz Inc. “As a leader in the generics market, Sandoz strives to constantly find new, differentiated ways to deliver affordable, high-quality healthcare solutions to the people who need them.”
In adults, rosuvastatin calcium tablets are used along with diet to lower the level of “bad” cholesterol (LDL), increase the level of “good” cholesterol (HDL), and/or lower the level of fat in blood (triglycerides). Rosuvastatin calcium tablets are used to treat adults who cannot control their cholesterol levels by diet and exercise alone. It is not known if rosuvastatin calcium tablets are safe and effective in people who have Fredrickson Type I and V dyslipidemias.
According to IMS Health, US sales for Crestor were approximately $6.7billion for the 12 months ending in May 2016. Sandoz will market rosuvastatin calcium tablets in the 5mg, 10mg, 20mg and 40mg strengths.
Rosuvastatin calcium is contraindicated in the following conditions:
Known hypersensitivity to product components
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Warnings and Precautions
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, atazanavir/ ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin if signs or symptoms appear.
Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter.
Most frequent adverse reactions (rate ≥ 2%) are headache, myalgia, abdominal pain, asthenia and nausea.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “launch,” “strategic,” “strives,” “will,” or similar terms, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from rosuvastatin calcium. 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 any potential new products will receive regulatory approval in the future, or that rosuvastatin calcium or any such potential new products 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 rosuvastatin calcium for sale either before or after the end of Sandoz expected 180-day exclusivity period; government, industry and general public 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 is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of over 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.