US FDA wants more data on Pfizer's Fablyn
This article was originally published in Scrip
Executive Summary
The US FDAhas issued Pfizerwith a complete response letter asking for more data on its selective oestrogen receptor modulator (SERM), Fablyn (lasofoxifene). The product is currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of bone fracture.
You may also be interested in...
P&G to co-promote Somaxon's Silenor in the US
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US.
GSK's shingles vaccine begins Phase III studies
GlaxoSmithKline has begun the Phase III clinical trials programme for its adjuvanted vaccine candidate (GSK1437173A) against herpes zoster for the prevention of shingles.
Optimer's fidaxomicin filing accepted in EU
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.