Andrea:
I do so to global regulatory agencies including the contact info (you provided) for FDA.
Just to provide the meaning of the "Discontinued Section" of the Orange Book, the link for the info is also provided below.
Discontinued Section
"Those drug products in the Discontinued Section of the Orange Book in which a determination has already been made that the products were not withdrawn for safety or efficacy reasons have "**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**" following the product strength. Those drug products are only reflective of citizen petitions approved since 1995. The identification of these drug products in the Discontinued Section of the Orange Book should avoid the submission of multiple citizen petitions for the same drug product. FR notices no longer applicable are removed from the Annual Edition (i.e., there is a currently marketed Reference Listed Drug and no applicable patent or exclusivity). Safety or Effectiveness Determinations List lists products that have current and removed notices. The list is updated periodically throughout the year. Notices issued during the year are added to the Electronic Orange Book Query in the month they become effective.
Generally, approved products are added to the Discontinued Section of the Orange Book when the applicant holder notifies the Orange Book staff of the products' not marketed status. Products may also be added if annual reports indicate the product is no longer marketed or other Agency administrative action (e.g., Withdrawal of an Application). Changes to the Orange Book are not affected by the drug registration and listing requirements of Section 510 of the Act."
Changes to the Orange Book
"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."
For further info, see
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm -------------------------------------------
www.RegulatoryDoctor.com Floyd VA
United States
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Original Message:
Sent: 07-27-2012 11:07
From: Andrea Chamblee
Subject: Discontinued ANDAs
www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance>. The contact info is kind of hidden, but it's included here: www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053133.htm For small business inquiries, contact Brenda Stodart, Pharm.D. at 301/796.6707 or CDERSmallBusiness @ fda.hhs.gov (remove the spaces around the @).">You can get a quick answer from FDA Small Business Assistance at <www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance>. The contact info is kind of hidden, but it's included here: www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053133.htm
For small business inquiries, contact Brenda Stodart, Pharm.D. at 301/796.6707 or CDERSmallBusiness @ fda.hhs.gov (remove the spaces around the @).
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Andrea Chamblee RAC, FRAPS
Director
FDA
Rockville MD
United States
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Original Message:
Sent: 07-26-2012 10:48
From: Lisa Apolis
Subject: Discontinued ANDAs
Hello,
Does anyone have experience on reactivating an ANDA that has been moved to the Discontinued section fo the Orange Book? What is OGD's view on this? Marketing was discontinued a few years ago due to the approved API supplier leaving the market. We would like to bring it back with a new API source. Is this just a PAS?
Any advice is greatly appreciated!
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Lisa Apolis
BLU Pharmaceuticals
Franklin KY
United States
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