FDA Hikes Generic Drug Application Fees for FY 2019

July 27, 2018

The FDA released its GDUFA II user fees for fiscal 2019 — including a significant hike for generic drug applicants.

The new GDUFA II fees, which take effect Oct. 1, raise large-size operation generic drug applicant program user fees from $1,590,792 to $1,862,167. For medium scale operations, the fee is increasing from $636,317 to $744,867, and for small operations the fee jumps from $159,079 to $186,217.

The agency is also upping fees for ANDA applications and drug master files. For ANDAs, the fee is set to rise from $171,823 to $178,799 and the fee for drug master files will go up from $47,829 to $55,013. All applicants that submit an ANDA must pay the FY 2019 filing fee on or after Oct. 1.

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