Diovan Generic Exclusivity Mystery Deepens After Judge Tosses Mylan Lawsuit
This article was originally published in The Pink Sheet Daily
Court says FDA handled changed USP monograph appropriately, but ruling sheds no new light on the status of first-filer Ranbaxy’s tentatively approved valsartan ANDA or when the first generic version of Novartis’ single-ingredient anti-hypertensive agent will enter the market.
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Mylan’s product launches as FDA tells Teva that the agency’s delay in granting tentative ANDA approval does not prevent forfeiture of exclusivity.
In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.
Sponsor’s assertion of a ‘floor effect’ cannot explain the lack of difference versus placebo on clinical endpoints, and there is no evidence that assessed biomarkers are reasonably likely to predict clinical benefit, agency says. Although advisory committee will focus primarily on efficacy, FDA also cites concerns about ‘grossly deficient’ product quality information.