FDA grants tentative approval to Amerigen's ANDA for generic version of Toviaz

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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 31^st 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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Amerigen Pharmaceuticals

Posted in: Pharmaceutical News

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