STELFONTA® USA Marketing Authorisation Progress

21 September 2020

The US Food and Drug Administration - Center for Veterinary Medicine (FDA-CVM) has concluded that all technical sections for the STELFONTA (tigilanol tiglate) application for marketing authorisation are complete. The final stage of administrative review has commenced, with formal registration as a veterinary pharmaceutical expected mid-November 2020 pending approval.

STELFONTA (tigilanol tiglate) was approved by the European Medicines Agency (EMA) in January this year, making it the first pharmaceutical treatment available for all grades of canine non-resectable, non-metastatic mast cell tumours (MCT).

QBiotics have partnered with Virbac, a global animal health company for the marketing and distribution of STELFONTA in the USA, UK, EU and Switzerland.