Forest COPD Combo Hits Roadblock En Route To NDA Filing
This article was originally published in Pharmaceutical Approvals Monthly
Forest is delaying submission of an NDA for aclidinium/formoterol to resolve FDA concerns about the formulation’s chemistry, manufacturing and control specifications.
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New drugs are hitting the COPD market, but largely offer incremental benefit over gold standards Advair and Spiriva. Given the modest efficacy improvement and increasingly price sensitive patients and payers, new higher-priced products may find the commercial market a challenge.
The twice-daily aclidinium, a long-acting antimuscarinic agent, should be available to wholesalers in the fourth quarter.
Forest Admits To Knowingly Obstructing FDA Inspection In Guilty Pleas On Levothroid, Celexa Marketing
Forest Pharmaceuticals reached a $313 million settlement with the Department of Justice to resolve criminal charges of obstructing an FDA inspection and distributing a misbranded drug and civil False Claims Act allegations.