Food and Drug Administration - May 26, 2005
Richard Klein and Kimberly Struble
Roche Pharmaceuticals, of Nutley, New Jersey, has issued a Dear Health Care Provider letter to inform the clinical community that commercial distribution of Fortovase, the 200-mg soft-gel formulation of saquinavir, will be discontinued by February 15, 2006.
The letter cites decreased demand for Fortovase as the reason for the product's discontinuation.
Invirase, another formulation of saquinavir manufactured by Roche Pharmaceuticals, will continue to be available in 200-mg and 500-mg formulations.
Roche suggests that physicians refrain from starting Fortovase treatment in their HIV-positive Patients at this time, and encourages prescribing health care providers to discuss appropriate alternative treatment regimens with patients currently receiving Fortovase.
The complete Dear Health Care Provider letter is available.
Richard Klein, Office of Special Health Issues
Kimberly Struble, Division of Antiviral Drug Products
Food and Drug Administration
050526
FD050506
SOURCE: Food and Drug Administration (FDA).
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