Hill Dermaceuticals, Inc., a privately-held pharmaceutical company based in Sanford, Florida at the Orlando-Sanford Airport, which develops, manufactures and distributes specialty prescription dermatology products, is pleased to announce that Tolak® (fluorouracil) 4% Cream, has been successfully registered in the United Kingdom and in 13 countries within Europe, including France, Germany, Spain, Italy, Belgium, Sweden, Norway, Netherlands, Denmark, Czech Republic, Slovakia, Austria and Portugal. The initial marketing launch will be in Germany.
Tolak® was developed by Hill Dermaceuticals for the treatment of Actinic Keratosis (pre-cancerous lesions) of the face, ears and/or scalp, and received its FDA approval in the fall of 2015, and its Health Canada approval in early 2019.
Tolak will be manufactured for European export exclusively by Hill Dermaceuticals at its Orlando/Sanford Airport facility. Pierre Fabre Derm-Cosmetique, a global player in dermatology and the second largest dermocosmetic company world-wide, has been granted marketing rights in the above-mentioned European countries as well as in other selected world-wide countries
Sanford, Florida, May 22, 2014 – Hill Dermaceuticals, Inc®, a privately held pharmaceutical company with 6 NDAs and that develops and manufactures prescription drugs focusing on Dermatologic diseases, announced that the United States Food and Drug Administration (“FDA”) has granted orphan drug designation to its investigational drug for Fungal Otitis Externa (Otomycosis).