Apr 30 2015
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.
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