Roche's (RHHBY) Genentech Receives FDA Committee Nod for Lucentis as DME Treatment
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Genentech, a member of the Roche Group (OTCBB: RHHBY), today announced that the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis® (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose.
The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so.
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The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so.
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