Sandoz launches generic version of Emend® capsules
Jan 04, 2017
Princeton, New Jersey, January 4, 2017– Sandoz today announced the U.S. market introduction of aprepitant capsules, 40mg, 80mg, and 125mg, a generic version of Emend®1 by Merck Sharp & Dohme Corp.
Aprepitant is prescribed for patients 12 years of age and older, in combination with other antiemetic agents to help prevent nausea and vomiting caused by certain chemotherapy medicines. It is also prescribed for adults to prevent nausea and vomiting after surgery. Aprepitant is not used for established nausea and vomiting. Aprepitant is not for chronic continuous administration.
“Sandoz is the first company to offer a generic of Emend capsules, which demonstrates our passion for bringing high-quality generic medicines to patients and health care professionals,” said Peter Goldschmidt, President of Sandoz Inc. “This launch complements our portfolio of medicines that address the side effects of cancer therapy, while offering cost savings to patients and health systems.”
According to IMS Health, U.S. sales for Emend were approximately USD 62m for the 12 months ending in Oct 2016.
Important Safety Information
Aprepitant is contraindicated in patients who are allergic to the any component of the drug, and for those patients who are concurrently taking pimozide. Before taking aprepitant, patients should tell their healthcare provider if they have liver problems, are pregnant or plan to become pregnant, breastfeeding or planning to breastfeed, or if they take birth control medicines containing hormones to prevent pregnancy.
Side-effects include (in adults taking aprepitant to prevent nausea and vomiting caused by chemotherapy) tiredness, diarrhea, weakness, indigestion, stomach (abdominal) pain, hiccups, decrease in white blood cell count, dehydration, and changes in liver function tests. In adults taking aprepitant to prevent nausea and vomiting after surgery, the most common side effects include constipation and low blood pressure (hypotension).
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
1EMEND is a registered trademark of Merck Sharp & Dohme Corp.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “passion,” “launch,” or similar terms, or by express or implied discussions regarding potential future product approvals or launches, or regarding potential revenues from generic aprepitant capsules or other products in the Sandoz portfolio of medicines that address the side effects of cancer therapy. 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 generic aprepitant capsules or any other products in the Sandoz portfolio of medicines that address the side effects of cancer therapy 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 generic aprepitant capsules for sale; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected safety, quality or 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 approximately 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.