Lannett Company, Inc. announced that it has commenced marketing Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, an internally developed product. Total U.S. sales of Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, according to IQVIA market, were approximately $68 million for the 12 months ending June 2021, although actual generic market values are expected to be lower.
"Our Abbreviated New Drug Application (ANDA) 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 Tim Crew, chief executive officer of Lannett. "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 USP, 200 mg/mL, bioequivalent and therapeutically equivalent to the reference listed drug (RLD) CellCept® Oral Suspension 200 mg/mL of Roche Palo Alto LLC, 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.
Mycophenolate Mofetil for Oral Suspension is subject to a Risk Evaluation and Mitigation Strategies (REMS) program. There is an approved REMS for this product to ensure the benefits of the drug outweigh the risks of first trimester pregnancy loss and congenital malformations. Lannett is a member of the shared Mycophenolate REMS program https://www.mycophenolaterems.com.
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