Tribute Pharma's IND Application For Bezalip Cleared By FDA - Quick Facts

(RTTNews) - Tribute Pharmaceuticals Canada Inc. (TBUFF.PK), a specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, announced that an Investigational New Drug application (IND) was submitted to the US FDA setting out the proposed development program for Bezalip SR (bezafibrate) tablets in patients with severe hypertriglyceridemia. The IND has been cleared by the FDA.

Tribute's development program has been based on guidance provided by the FDA during an end of Phase II meeting held in March 2012. The company said it intends to submit a Special Protocol Assessment to the FDA at its earliest convenience that incorporates all substantial scientific issues currently available to establish safety and efficacy as part of the development program.

Bezalip SR is a pan-PPAR activator that has been approved and marketed in more than 40 countries outside of the United States. Tribute currently markets Bezalip SR in Canada under an exclusive Canada/USA license from Actavis Group PTC ehf (ACT).