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COPYRIGHT 2001 Asia Pulse Pty Ltd
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ATLANTA & VANCOUVER, Feb 5 PRNewswire - AsiaNet -Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS), and QLT Inc. (Nasdaq: QLTI; Toronto) today announced that the United States Food and Drug Administration (FDA) has issued an approvable letter to expand the use of Visudyne(TM) (verteporfin for injection) therapy. Currently, Visudyne is approved for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50. The expanded indication would include treatment of predominantly classic subfoveal CNV caused by other macular conditions such as pathologic myopia (PM) and ocular histoplasmosis syndrome (OHS), among others.
An FDA approvable letter typically indicates that the agency intends to approve the application. In the letter the FDA states that it has reviewed the application and requests further clinical information relating to OHS, which is expected to fulfill the necessary criteria to obtain the broad supplemental indication for Visudyne therapy. The additional information has been submitted to the agency. Final approval is expected to be issued in the next few months....
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