FDA Approves Resumed Marketing of Tysabri MS Drug

WASHINGTON, D.C. - The FDA has approved an application for resumed marketing of Biogen-Idec's Tysabri multiple sclerosis drug, saying the medication will be subjected to a special restricted distribution program.

On June 6, the FDA said that following a thorough review of Biogen-Idec's risk management plan and proposed changes to its original marketing application, the agency determined that Tysabri (natalizumab) can be made available under the TOUCH Program, which will ensure that the drug will only be prescribed, distributed and infused by prescribers, infusion centers and pharmacies registered with the program.

The TOUCH Program will also require that Tysabri only …