PRESIDENT’S UPDATE OCTOBER 2021
Recently, the FDA issued a statement indicating it was changing the therapeutic equivalence ratings for several products that were linked to two Clinical Research Organizations (CRO) due to not following applicable statutory requirements related to bioequivalence studies, affecting over 100 items in the market. These items were changed from an “AB” Orange Book Rating to “BX”. These products are still FDA approved and there is no change to quality and safety and the FDA is not requiring any market action. These products may or may not be substitutable based on your local statutes.
Effective immediately, Auburn will be quarantining the affected items until there’s resolution. A link to the “Auburn BX Items for Quarantine 9-23-21” will be available on our website. Auburn is working closely with our manufacturing partners as they work with the FDA to restore their AB ratings. In the meantime, we will make our best effort to ensure our customers’ needs are met and will implement efforts to carry an AB rated equivalent secondary until the issue is resolved.
A link provided for questions and answers from the FDA website, “Questions and Answers Regarding Data Integrity Vilations at Clinical Labs” will also be available at auburngenerics.com. If you have questions regarding the product ratings, please check your local state board of pharmacy regulations.
We will continue to provide information as it becomes available.
Auburn’s inventory continues to grow. Check out these two new items: Bystolic by Ascend in 30 and 90 counts. 2.5, 5, 10 & 20mg strengths and Difluprednate Ophth solution by Sandoz.
Coming as soon as November, generic Narcan (Naloxone) 4mg nasal spray and Gilenya (Fingolimod) 0.25 caps.
To easily find the October specials, simply type MONTH in the search bar; we also have weekly deals (WEEK) and recent price drops on many items. Visit our website, www.auburngenerics.com to help you save on your generic purchases and visit GenericBid.com for additional savings.