Drugs

FDA Reminds Drug Makers About Status Report Due 2/14

FDA is reminding all ANDA and NDA holders about a one-time report that is due 2/14 on the market status for all approved drug products. The report is mandated in the recently enacted FDA Reauthorization Act of 2017 under Section 506I, which calls on all NDA and ANDA holders to review information published in the agency’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), and submit a one-time written report to FDA indicating that:

the NDA and ANDA holder’s drug(s) in the active section of the Orange Book are available for sale; or
one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.

The agency has published information on how NDA and ANDA holders can submit the one-time marketing status report to FDA.

FDA Reminds Drug Makers About Status Report Due 2/14

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