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Latest From Apotex Inc.
Can The Generics Industry Leverage Its COVID Success To Achieve Its Policy Goals?
Vaccine makers get all the credit (among those who think any credit is due) for ending the pandemic, but generic sponsors want to remind policymakers that their plants stayed open during the worst of COVID-19 to ensure that hospitals were stocked and medicines for chronic conditions didn’t run short.
Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.
Generic Application Mystery: Few ANDAs Withdrawn To Start FY 2023
In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.
Ontario Welcomes Biosimilar Switching Policy Following Extended Campaign
Ontario has joined several other Canadian provinces and territories by implementing a biosimilar switching policy for Ontarians taking biologic drugs.
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