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news.The US Food and Drug Administration (FDA) has granted tentative approval for Amerigen Pharmaceuticals' abbreviated new drug application (ANDA) for a generic version of Toviaz (Fesoterodine Fumarate Extended-release Tablets, 4mg and 8mg).
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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.
In the US, Pfizer markets Toviaz to treat overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
According to IMS Health, US sales of Toviaz were about $215m for the 12 months ended 31 December 2014.
According to Amerigen, it 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 is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China.