Lannett intros generic Cellcept
Lannett is offering mycophenolate mofetil for oral suspension, 200 mg/mL, an internally developed product. The medication is the generic of Roche Palo Alto’s CellCept.
It is indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immune-suppressants.
[Read more: Lannett inks distribution agreement for generic Spiriva Handihaler]
"Our Abbreviated New Drug Application for Mycophenolate Mofetil for Oral Suspension received a first-cycle approval from the FDA, which underscores the quality of our filing, as well as our product development team," said Lannett CEO Tim Crew. "Moreover, this approval is a noteworthy accomplishment, given that the product represents a new dosage form for us, powder for oral suspension. Currently, only two other competitors market generic Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, in the U.S.”
Mycophenolate mofetil for oral suspension 200 mg/mL, had a market value of approximately $68 million for the 12 months ending June 2021, although actual generic market values are expected to be lower, according to IQVIA.