FDA’s Opioid To-Do List Could Redefine Pain Market For Brands, Generics
Supporters of narrowing opioid drugs’ non-cancer pain indication tell FDA that pain patients often suffer the consequences of addiction and misuse.
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Purdue Petition Seeks FDA Commitment To “Adapted” Studies For OxyContin Generics
Company says a generic should be equivalent or better than reformulated OxyContin on all the tests to ensure it has equivalent abuse-deterrent capabilities.
FDA’s Parks Expands REMS Portfolio With Move To ODE II Deputy Slot
Currently the head of the Division of Metabolic and Endocrinology Products, Parks has handled drug safety controversies in diabetes and obesity products.
Strategy Of A Corporate Split: An Interview With Mallinckrodt’s Mark Trudeau and Matt Harbaugh
CEO-designate and CFO for the Mallinckrodt specialty pharma spin-out from Covidien discuss the strategy for differentiating its products in a competitive analgesic space. Despite a goal of becoming a leading specialty pharma, the new company does not plan to divest its imaging or active pharmaceutical ingredient businesses.