Acthar Gel Medicaid Rebates: Mallinckrodt Loses 'Gamble' Over FDA's NDA Numbering System
Mallinckrodt must pay $650m in retroactive Medicaid rebate payments; case shows how application filings can impact CMS reporting requirements and price-based reimbursements.
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The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
US government says Mallinckrodt avoided millions in Medicaid rebates by claiming Acthar’s added indication was approved as a new NDA rather than a supplemental application.
Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.