Sandoz launches SyedaTM, a generic version of Yasmin®
Princeton, New Jersey; June 8, 2011 - Sandoz today announced the US Food and Drug Administration TM (FDA) approval and US launch of Syeda (drospirenone 3 mg /ethinyl estradiol 0.03 mg tablets), a generic equivalent of Yasmin®.
Syeda is indicated for the prevention of pregnancy in women who choose to use an oral contraceptive. It is the fourth such product launched by Sandoz in the US this year, following the recent launches of AltaveraTM, IntrovaleTM and LorynaTM.
"The launch of Syeda further demonstrates our commitment to serving the needs of women in the US," said Don DeGolyer, President of Sandoz Inc. "Syeda is another important addition to our oral contraceptive portfolio, which we will continue to build in order to further increase access to affordable birth control options."
Among women in the US who practice contraception (approximately 62 percent of women aged 15 to 44), 28 percent choose oral contraceptives, which are the most commonly used form of contraception. 1
According to IMS Health, US sales for branded and generic versions of Yasmin® were approximately USD 365 million for the 12 months ending in April 2011. Sandoz is marketing Syeda in a dosage regimen consisting of 21 active film-coated tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol, and seven inert (without hormones) film-coated tablets. This dosage regimen is identical to that of Yasmin®.
Important Safety Information Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use, including blood clots, stroke, and heart attack. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. Syeda also contains drospirenone, a different kind of hormone that for some may increase potassium too much.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy
For full safety information, please see the Syeda Prescribing Information available in the product catalogue at www.us.sandoz.com.
Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "launches," "launch," "launched," "commitment," "will," or similar expressions, or by express or implied discussions regarding potential future approvals of additional oral contraceptive products, or regarding potential future revenues from Syeda or such other 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 any additional oral contraceptive products will be submitted or approved by Sandoz for sale. Nor can there be any guarantee that Syeda or any such other 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 Yasmin®; unexpected product development difficulties; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing difficulties; 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.
About Sandoz Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by valid and enforceable third-party patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in about 130 countries. Key product groups include cardiovascular medicines, anti-infectives, treatments for central nervous system and alimentary tract disorders, oncology and respiratory therapies, as well as medications for blood and blood forming organ disorders. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances. 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), and Oriel Therapeutics (US). In
2010, Sandoz employed more than 23,000 people (full-time equivalents) worldwide and achieved net sales of USD 8.5 billion for the full year. *** For further information Sandoz US Communications: Ted Deutsch +1 609 627 5287
Sandoz Global Communications: Marija Mandic +49 8024 476 2597
Yasmin® is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.