Zydus gets FDA approval for generic mycophenolate mofetil
This article was originally published in Scrip
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.
You may also be interested in...
A senior executive shares insights around how the global logistics provider is preparing to deliver the upcoming COVID-19 vaccines across the world. While the company has prior experience with the "deep frozen" temperatures needed for some candidates, there will still be specific challenges and complexities involved.
The WHO’s new "living guideline" against remdesivir’s use in hospitalized patients notwithstanding, some key opinion leaders in India see a role for the antiviral, but underscore that COVID-19 is still in its infancy and all repurposed therapies for the disease still have a long way to go. They also see the US remdesivir studies as more robust.
More patent-related turbulence appears ahead for Novartis’s sacubitril/valsartan combination in India, with Torrent emerging as the new challenger. The companies are engaged in a legal battle and the Indian firm is also seeking a revocation of the patent on the star heart failure treatment.