FDA OKs Teva's generic Famvir
The US Food and Drug Administration has granted final approval for Israel-based Teva Pharmaceutical Industries' Abbreviated New Drug Application to market its generic version of Swiss drug major Novartis' Famvir (famciclovir) tablets, 125mg, 250mg and 500mg. The brand product had annual sales of around $200.0 million in the USA for the 12 months ended June 30, based on IMS Health data.
As the first company to file an ANDA containing a Paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
A patent infringement suit was brought against Teva in April 2005 involving its Paragraph IV certification to US Patent No 5,246,937 related to the Israeli firm's famciclovir products. A hearing is scheduled for September 5, in the US District Court for the District of New Jersey regarding Novartis' motion for a preliminary injunction in that action. Both parties have agreed not to launch a generic famciclovir product until the conclusion of the hearing.
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