US FDA accepts Sirion's filing for ocular herpes drug
This article was originally published in Scrip
The US FDAhas accepted for review Sirion Therapeutics' NDA for ganciclovir ophthalmic gel 0.15% as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus.
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.