Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus. The FDA has issued an action date in late fall of 2009, under the Prescription Drug User Fee Act.

The details can be read here.