IVAX receives final approval for fluticasone nasal spray across Europe
IVAX Corporation received final mutual recognition procedure (MRP) approval from the Medicine and Healthcare Products Regulatory Agency (MHRA) for fluticasone nasal spray in eleven countries across Europe.
It is expected that this approval will be followed by national marketing authorisation and launched in each country over the next few months. Fluticasone is the generic equivalent of flixonase (known in the US as flonase) marketed by GlaxoSmithKline for the treatment of rhinitis, claims a company release.
There are no other known generic alternatives presently marketed in Europe.
IVAX' fluticasone nasal spray has already been approved in the U.K. and was launched in May of this year. The company also has an ANDA for fluticasone nasal spray pending with the US FDA.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceutical and veterinary products in the US and internationally.