FDA requires a REMS for Lilly's long-acting olanzapine
This article was originally published in Scrip
The US FDAhas issued Lillywith a complete response letter for its olanzapine long-acting injection (LAI) – a once-monthly treatment for the acute and maintenance therapy of schizophrenia in adults, which is a long-acting version of its antipsychotic Zyprexa (olanzapine).
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.