This is a discussion on Genentech issues 2nd "Dear Healthcare Provider letter" re: PML with Raptiva within the FDA Recalls, Market Withdrawals and Safety Alerts forum, part of the Industry News and Updates category; The first "Dear Healthcare Provider letter" was issued in October 2008 by Genentech, warning of a case report ...
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The first "Dear Healthcare Provider letter" was issued in October 2008 by Genentech, warning of a case report of progressive multifocal leukoencephalopathy (PML) with a patient using Raptiva® (efalizumab). At the same time, the prescribing information was updated to include a boxed warning. The 2nd case of PML was reported in late October 2008, as part of the company's ongoing safety monitoring and surveillance program.
News article 11/08 Genentech press release 11/08 |
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