The mycophenolate mofetil hydrochloride (HCl) for injection is the generic version of Roche's CellCept
and is the first and currently the only generic injectable available.
G2: (Cyclosporine, Cellcept
, IV methyl Prednisolone and oral Prednisolone).
During the Christmas snow, one kidney patient was forced to wait three weeks for Cellcept
, a drug he needed to stop his body rejecting a recent transplant.
That compared with nearly 34 percent with a placebo and standard therapies, which typically include immunosuppressant drugs such as Roche's CellCept
and steroids such as prednisone.
Azam U: Aspreva completes expanded patient enrollment in phase III clinical trial for CellCept
in pemphigus vulgaris.
In fact, the REMS being developed for CellCept
and Myfortic call for physician training and certification and a pregnancy registry, according to an FDA statement.
The Food and Drug Administration and Roche Holding AG last month revised the label of transplant drug CellCept
to include a new warning about cases of PRCA.
The required label changes affect the following drugs used to help prevent rejection of transplanted organs:--Rapamune (sirolimus) Sandimmune (cyclosporine) and cyclosporine generics--Neoral (cyclosporine modified), and generics - Cellcept
(mycophenolate mofetil) and generics--Myfortic (mycophenolic acid) The FDA is requiring the labeling changes based on its review of reported adverse events.
(oral mycophenolate mofetil, Aspreva Pharmaceuticals Corp.
Organ Transplant Medications (anti-rejection and other) Neoral or Prograf $1,500/month Cellcept
$800/month Septra $7.
The plant, which went into commercial scale production around November 2006, is already shipping Cellcept
, which is used for the prevention of organ rejection in transplant patients, at full capacity.
is Roche's leading immunosuppressant or "anti-rejection" drug used in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney and liver transplants.