Lannett Delivers On Internal Pipeline With Mycophenolate Mofetil Launch
Points To Technical Barriers And Limited Competition On Roche’s CellCept
Lannett has launched its internally-developed generic mycophenolate mofetil 200mg/ml oral suspension in the US, highlighting a first-cycle FDA approval as evidence of its capabilities as well as pointing to limited competition on the rival to Roche’s CellCept.
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With five “large, durable assets” in its pipeline, Lannett is confident that post approval these products have the potential to transform the company. This includes the generic version of Boehringer Ingelheim’s Spiriva Handihaler (tiotropium bromide) recently added to Lannett’s respiratory generics portfolio.
Lannett has added another respiratory generic to its development partnership with China’s Respirent, in the form of a rival to Boehringer Ingelheim’s tiotropium-based Spiriva Handihaler.
After receiving feedback from the FDA, Lannett has announced that it is on track to submit an investigational new drug application for its insulin glargine candidate to the agency later in 2021. Following this, the company plans to file a biologics license application in 2022 and launch the product in 2023.