Orange+Book

=Orange Book Questions=

[17-Jun-2011]

Subject:
Orange Book, delisting, user fees

Question:
Is the Orange Book now using data from SPL to update its listings? Do Orange Book staff reference eListings to update the Orange Book listings?

Answer:
//(Answer Text)// The Orange Book is currently updated from application Information. When an NDA is withdrawn, the Orange book is updated. The Orange Books staff do not receive any input from SPL delistings at this time.

Delisting an NDC via eList will change data in the NDC Directory, and will be shown on DailyMed, but does not currently affect the Orange Book updates.

The applicant holder should continue to inform Orange Book directly for market changes. NDA application Rx user fee market status is very accurate since user fees are billed for active products. Generic user fees coming in 2012 may also impact accuracy of ANDA market status depending on what the final criteria are. Often the Orange Book staff don't know products are not being marketed until the applicant holder submits a request to withdraw the application.

Reference(s):
[|Orange Book in PDF Form] [|Searchable Version of Orange Book]

From the monthly [|Cumulative Supplement]section 1.2: Every effort is made to ensure the Cumulative Supplement is current and accurate. Applicant holders are requested to inform the FDA Orange Book Staff (OBS) of any changes or corrections. The OBS can be contacted by email at drugproducts@fda.hhs.gov. Send Changes by FAX: 240-276-8974;mail to: FDA/CDER Orange Book Staff, Office of Generic Drugs, HFD-610, 7620 Standish Place Rockville, MD 20855-2773

From the [|Annual Edition] Section 1.12: Every effort is made to ensure the Annual Edition is current and accurate. Applicant holders are requested to inform the FDA Orange Book Staff(OBS) of any changes or corrections. Please inform the OBS when products are no longer marketed. Notification of the Orange Book staff to include the newly approved product in the Discontinued Drug Product List rather than parts 1, 2, or 3 of the List (as discussed in Section 1.1) must occur by the end of the month in which the product is approved to ensure that the product is not included in the "active" portions of the next published Orange Book update
 * 1.12 Changes to the Orange Book **

We can be contacted by email at __ drugproducts@fda.hhs.gov __. Send Changes by FAX: 240-276-8974; mail to:

FDA/CDER Orange Book Staff, Office of Generic Drugs HFD-610, 7620 Standish Place, Rockville, MD 20855