Starpharma Holdings Limited, (ASX:SPL) says the FDA has granted a fast track designation as well as a Qualified Infectious Disease Product designation, for its VivaGel product.
VivaGel is used for the treatment and prevention of bacterial vaginoisis in women.
Starpharma has estimated that the market relating to the treatment and prevention of this infection is worth in excess of US$1 billion.
The company says it’s a very positive commercial development which expedites the path to US market entry for VivaGel.
Starpharma posted a net loss of $22.7 million at 30 June 2016.