Arbor Emphasizes Risks Of Its Own Product In Suit Against US FDA To Block Nymalize Generics
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.
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Nymalize, an oral formulation of brain hemorrhage treatment nimodipine, aims to minimize serious risks associated with incorrect administration of older forms of the drug.
FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.
Industry executives note lessons learned from ‘fascinating’ approaches DOJ and states have taken in recent settlements, from restrictions on Novartis speaker programs to targeting McKinsey’s marketing advice. Chart includes details of 18 settlements since January 2020.