Impax receives FDA approval for generic version of Intuniv (guanfacine)

Third generic product approved since the resolution of the warning letter at the Hayward facility.

Fred Wilkinson, President and CEO of Impax stated: "Since the resolution of the warning letter at the Hayward facility in early September, the FDA has approved three generic products from this facility in the last 5 weeks. Generic guanfacine was one of the products waiting for the resolution of the warning letter and we did not include it in the 14 potential generic product launches for 2015. We are now evaluating the viability of this very competitive multi-player market and potential commercialization of this product. Additionally, we will continue to work with the FDA toward approval of our pending Abbreviated New Drug Applications at our Hayward facility."

According to IMS Health (NSP), US brand and generic sales of guanfacine extended-release tablets 1 mg, 2 mg, 3 mg and 4 mg were approximately $689 million for the 12 months ending in August 2015.