Propranolol Hydrochloride U.S. & E.U. Approved to Treat Infantile Hemangioma


Propranolol Hydrochloride FDA Approved to Treat Infantile HemangiomaUPDATE: On May 6, 2014, Propranolol was approved by the European Commission for treatment of infantile hemangioma.

Infantile hemangioma, or an overgrowth of blood vessels on or under the skin of infants is a benign vascular condition. As a common non-life threatening tumor of the skin, infantile hemangioma occur during the first four weeks of infancy. The use of Propranolol Hydrochloride to treat nasal infantile hemangiomas has proven in clinical trials to effectively alleviate the hemangioma and eliminate the need for surgical intervention in roughly sixty percent of neonatal patients. With the approval of Hemangeol (Propranolol Hydrochloride) by the FDA on March 17, 2014, marketers Pierre Fabre Dermatologie offered their excitement at the announcement of their milestone. As of now Propranolol Hydrochloride, known as the brand name Hemangeol, is the first and the only FDA approved treatment for proliferating infantile hemangioma which requires systemic therapy. A positive opinion of Hemangeol was disseminated from the European Medicines Agency in February of 2014.

Propranolol Hydrochloride was studied extensively as an oral solution in various doses for infants’ ages five weeks old to five months old. A comprehensive randomized study involved four different dosages of Propranolol Hydrochloride, dispensed for either three or six months’ time, and at either one or three milligrams per day, based on weight. A placebo study group was also involved. This randomized study produced results demonstrating that the patient group who received three milligrams per day for six months’ time had a 60..4 percent success rate as compared with the placebo group. This high success rate included the complete resolution of the hemangioma. After treatment ceased only a little over eleven percent of patients needed retreatment to completely resolve their hemangiomas. Adverse reactions were uncommon, and included sleeping problems, bronchial infections and diarrhea. The adverse reactions noted led to only two percent of patients treated with Propranolol Hydrochloride needing to withdraw from the study.

LGM Pharma supplies Propranolol and Propranolol Hydrochloride CAS# 318-98-9, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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