Sandoz Pharma A.G. Receives FDA Approval for Generic Toprol XL(R) 50 mg Tablet
PRINCETON, N.J., May 21 /PRNewswire/ -- Sandoz announced today that the US Food and Drug Administration has granted final approval to its abbreviated new drug application for metoprolol succinate 50 mg extended release tablets, a generic equivalent of Toprol XL(R).
"We are pleased to have received final FDA approval for this product," said Dr. Bernhard Hampl, president of Sandoz Inc. "It will be a strong complement to our existing product line, which includes metoprolol succinate 25 mg extended release tablets."
Launch plans and timing for metoprolol succinate 50 mg ER have not been finalized by 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 patents. Sandoz has a portfolio of more than 840 compounds in over 5,000 forms worldwide and sells its products in more than 110 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these drugs along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to the strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and Eon Labs (U.S.). In 2006, Sandoz employed approximately 21,000 people worldwide and posted sales of USD 6 billion.
The foregoing release may contain forward-looking statements regarding potential additional marketing approvals or future sales of metoprolol succinate 50 mg extended release tablets. Any such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with metoprolol succinate 50 mg ER to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that metoprolol succinate 50 mg ER will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. Management's expectations regarding metoprolol succinate 50 mg ER could be affected by various risks and factors referred to in the company'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. Sandoz is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
For further information Sandoz US Communications: Charles A. Bruns 609.627.8881 Toprol XL(R) is a registered trademark of AstraZeneca PLC.Sandoz
CONTACT: Charles A. Bruns of Sandoz US Communications, +1-609-627-8881
Web site: http://www.us.sandoz.com/