Pharmaceutical Business review

FDA approves Actonel with calcium

The companies say that this is the first prescription osteoporosis therapy to include calcium. The new treatment option comes in light of a recent Surgeon General’s Report on Bone Health and Osteoporosis which emphasizes the need for osteoporosis regimens to be simplified and organized.

“Calcium is a critical component to the effectiveness of osteoporosis therapy,” said Dr Steven Goldstein, professor of obstetrics and gynecology, at the New York University School of Medicine. “Actonel with calcium is an important new tool that helps simplify the osteoporosis regimen by conveniently delivering two important elements – the bisphosphonate and the calcium – in one unique package.”

Procter & Gamble is currently in patent litigation against Israeli drug manufacturer Teva over a generic equivalent of Actonel that Teva has developed. If Teva is allowed to continue with commercialization of its generic equivalent, P&G and Sanofi Aventis might hope that this new packaging of the drug will give their branded version the edge over its potential generic competitor.