Valera submits NDA on Supprelin-LA to US FDA

The USA's Valera Pharmaceuticals has submitted a New Drug Application to the Food and Drug Administration for Supprelin-LA (histrelin), a 12-month implant for early onset of puberty in children (central precocious puberty), which involves the premature development of secondary sexual characteristics in young children due to increased secretion of sex hormones.

In November 2005, the FDA granted the agent orphan drug designation, which provides seven years marketing exclusivity from the date of approval, as well as certain economic benefits and tax credits. In addition, Valera noted that Supprelin-LA is the second product to emerge from its pipeline that utilizes its proprietary and patent-protected Hydron delivery technology.

David Tierney, Valera's chief executive, noted that, "with the potential commercialization of Supprelin-LA in 2007, we anticipate having at least three products on the market next year." In addition to our currently marketed histrelin product, Vantas, this also includes Valstar (valrubicin), the only approved drug for certain urinary bladder cancer patients, which Valera expects to launch around year end.