Zydus gets FDA approval for generic mycophenolate mofetil
This article was originally published in Scrip
Executive Summary
Zydus Cadila has received US FDA approval to market mycophenolate mofetil tablets 500mg and mycophenolate mofetil capsules 250mg. The products are generic versions of Roche's CellCept, which is indicated for the prevention of organ rejection in patients receiving kidney, heart or liver transplants. Sales of mycophenolate mofetil tablets and capsules were $648 million and $316 million respectively last year. The Zydus group now has 46 FDA approvals and has filed 92 ANDAs so far. Mylan, which has also received approval for generic CellCept, said that it has commenced shipping both products.
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