CASTRES, France and PARSIPPANY, N.J. — Pierre Fabre Dermatologies announced that it received authorization from the Food and Drug Administration to market the pediatric drug Hemangeol (propranolol hydrochloride).
It is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy," the company said. Infantile hemangioma is a vascular benign tumor that affects 3% to 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,” said Dr. Jean-Jacques Voisard, dermatologist, general manager of Pierre Fabre Dermatologie.
Hemangeol will be available in June 2014.