LYNDHURST, N.J., April 30, 2015 /PRNewswire/ -- Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Toviaz® (Fesoterodine Fumarate Extended-release Tablets, 4mg and 8mg). Based upon available information, Amerigen believes that it is a first applicant to file an ANDA for Toviaz® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act.
Pfizer markets Toviaz® in the U.S. for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. U.S. sales of Toviaz® were approximately $215 million for the 12 months ended December 31st 2014, according to IMS Health.
Amerigen is challenging certain patents listed in the Orange Book for Toviaz® and a trial in the Federal District Court in Delaware is currently scheduled for July 2015.
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.
SOURCE Amerigen Pharmaceuticals