SkyePharma reveals doubts over US approval for Flutiform
This article was originally published in Scrip
SkyePharma has expressed doubts over the likelihood of a US approval for its lead product, the combination asthma drug Flutiform (fluticasone propionate plus formoterol fumarate); following a discussion it had with the US FDA.
You may also be interested in...
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US.
GlaxoSmithKline has begun the Phase III clinical trials programme for its adjuvanted vaccine candidate (GSK1437173A) against herpes zoster for the prevention of shingles.
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI.