How Pfizer Warning Letter Tarnished Sandoz/Momenta's Glatopa Launch
An FDA warning letter to a contract manufacturer, Pfizer, delayed Sandoz/Momenta's Glatopa 40 mg launch, reducing projected revenues and leading Momenta to consider selling assets.
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Teva said its 2018 revenue guidance reflected an April launch for the 40 mg dose of Glatopa, but Sandoz and partner Momenta announced FDA approval and the US launch of their less frequently administered Copaxone generic on Feb. 13.
FDA cleared Mylan's generic version of Copaxone 40mg even after management warned investors not to expect action until 2018. Mylan said it will launch "imminently, but Teva said a launch ahead of the pending appeals case would be "at risk."
Infractions that have delayed Copaxone generic in plant Pfizer acquired when it bought Hospira suggest that pattern of quality issues may be continuing. Warning letter assigns eight tasks related to particulate contamination.