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Lupin Ltd.

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Latest From Lupin Ltd.

Mylan Triumphs In Tecfidera Patent Challenge

Following a district court decision invalidating the '514 patent for Tecfidera, Mylan says it looks forward to launching a generic after final FDA approval is granted, despite Biogen saying it will appeal the ruling. The ANDA has a November action date.

Intellectual Property Legal Issues

COVID-19 Demand Gives Lupin Optimism On Albuterol

Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.

Strategy Coronavirus COVID-19

Metformin Testing Prompts New Finding Of NDMA And Cancer Risk

The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks.

Manufacturing Quality

New Testing Prompts New Finding Of NDMA, Cancer Risk In Metformin Products

The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks. 

Manufacturing Quality
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