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The market is well established

The deadline for defendants to submit their expert reports is December 23, 2024

However, FDA will review whether the DMF has appropriate sections if the manufacturer pays the DMF fee required under the Generic Drug User Fee Act (GDUFA)

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Tirzepatide: A review in type 2 diabetes

Typically 2 to 4 weeks for an initial decision, extending to 6 to 10 weeks if denied and appealed