Upon final approval, Synthon’s generic Amlodipine-Valsartan will be the AB-rated generic equivalent of Novartis’ Exforge®. Exforge® is combining the active ingredients of an angiotensin receptor blocker - Diovan® (valsartan) - and a calcium channel blocker - Norvasc® (amlodipine) - with the convenience of a single, once-daily tablet. The product was launched in the U.S. by Novartis in June of 2007.
The brand product had annual sales of approximately $ 263 million in the United States, based on IMS Midas sales data.
About Synthon
Synthon’s ANDA of Amlodipine-Valsartan is one of multiple approved and pending ANDA’s of the company and confirms Synthon’s track record in filing and launching generic drugs at the earliest possibility. The tentative approval for this ANDA is another example of Synthon’s objective to provide patients with high quality, affordable medicines.
Synthon is an international pharmaceutical company which develops, manufactures and out-licenses specialty generics. Recently Synthon has started research and development in the biopharmaceutical area, which will result in a new generation of medicines. Employing more than 1250 staff worldwide, Synthon is headquartered in the Netherlands and has subsidiaries in eight other countries. Synthon offers a wide portfolio of high quality alternatives to innovative medicines with many interesting early entry opportunities, which are made available worldwide through local marketing partners.
Exforge® is a trademark of Novartis AG
Diovan® is a trademark of Novartis Corporation
Norvasc® is a trademark of Pfizer, Inc
For further information on Synthon Pharmaceuticals Inc. please see www.synthon-usa.com or mail to pr@synthon.com.