Multiple Sclerosis - FDA Statement On Tysabri Review Time

... Biogen Idec and Elan announced on March 22, 2006, that the Food and Drug Administration (FDA) had extended the regulatory review period for the reintroduction of Tysabri (natalizumab) for multiple sclerosis (MS) by up to 90 days. Under the Prescription Drug User Fee Act, extensions to the review period for an application can be triggered by a substantive submission from the sponsor... click link for more info. ...