US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy.”

Hemangeolis an oral solution specially developed for safe and effective use in children and will be available in the USA in June of this year, the company stated. Infantile hemangioma is a vascular benign tumor that affects between 3% and 10% of newborns.

“This collaboration has endowed pediatric dermatology with a new therapy that fulfills an unmet medical need and thousands of American children may now benefit from this new therapy each year,” commented Jean-Jacques Voisard, Dermatologist, general manager of Pierre Fabre Dermatologie, a unit of independent French drugmaker Pierre Fabre.