FDAnews Drug Daily Bulletin

Johnson & Johnson (J&J) will sell Biovail’s opioid Ultram ER in markets outside the U.S. under an expanded 10-year supply agreement for the painkiller.

Ortho-McNeil, a subsidiary of J&J, markets Ultram ER (tramadol HCI) in the U.S. under an agreement with Biovail, which holds the new drug application for the product.

Under the expanded agreement, J&J subsidiary Janssen Pharmaceutica will market Ultram ER in 86 countries in Central and Eastern Europe, the Middle East and Latin America. Biovail will manufacture the drug, and J&J will be responsible for all promotional and regulatory costs, including the management of regulatory approvals, according to Biovail.