GSK and Xenoport to withdraw and resubmit US NDA for Solzira in RLS
This article was originally published in Scrip
GlaxoSmithKlineand Xenoporthave decided to withdraw and resubmit their NDA for approval of Solzira (gabapentin enacarbil) extended-release tablets, for the treatment of moderate to severe restless legs syndrome – which was filed with the US FDA in September (Scrip Online, September 18th, 2008).
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.