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.
You may also be interested in...
Novartis Sheds Vildagliptin Trademark In India Ahead Of Patent Expiry
Eris Lifesciences has acquired a Novartis trademark for vildagliptin, a DPP-4 inhibitor that has been the subject of a torrent of alleged infringement-related legal action in India. Pricing for the acquired brand will be interesting to watch from now on as a patent on vildagliptin is set to expire soon.
Cipla's COO Steps Down
Cipla’s global chief operating officer is leaving the company to pursue new interests, amid a spate of top-level exits that have marked the pharma sector in India in 2019.
Newbie Remogliflozin Gives Competition A Run For Their Money
Remogliflozin prescriptions gallop in India and Glenmark expects the ‘affordable’ therapy to take share from other SGLT2 inhibitors.
Need a specific report? 1000+ reports available
Buy Reports