Amneal Wins First Priority Review ANDA Approval

Regulatory NewsRegulatory News | 31 October 2018 |  By 

Amneal’s abbreviated new drug application (ANDA) for Carmustine for injection was the first ANDA to win a priority review – a new designation for generic drugs thanks to the FDA Reauthorization Act of 2017 (FDARA).

FDA told Focus Amneal has won a priority review ANDA approval because it submitted a pre-submission facility correspondence prior to their original submission.

According to that revised pre-submission guidance, generic drug applicants can pre-submit complete, accurate facility information in advance of a priority ANDA, prior approval supplement or amendment under the Generic Drug User Fee Amendments of 2017 (GDUFA II).

“One of the key requirements of this section is that pre-submitted facility information must be unchanged relative to the application submission date,” the guidance notes.

Amneal said it intends to launch the injectable generic in November. US market annual sales for the 12 months ended August 2018 for Carmustine for Injection USP, 100 mg/vial is estimated to be about $84 million, according to IQVIA.

In addition to priority review, FDARA also features a Competitive Generic Therapy (CGT) designation, for which three ANDAs have been approved. The CGT designation allows generic drugs to come to market faster than they otherwise would have, but only in cases where there is one approved competitor in the active section of the Orange Book.


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