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August 30, 2021
“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.”