Overview & Basics

The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:Contain the same active/key ingredient;Have the same strength;Use the same dosage form (for...

Aytu Biopharma – 716599 – 09/09/2025

Recipient: Recipient Name Josh Disbrow Recipient Title Chief Executive Officer Aytu Biopharma 7900 E. Union Avenue, Suite 920Denver, CO 80237United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING...

FWD Care, Inc. dba FWD – 716696

Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTERSeptember 9, 2025FWD:This letter is to advise you that the United...

Novo Nordisk Inc. – 716495

Recipient: Recipient Name Maziar Mike Doustdar Recipient Title President and Chief Executive Officer Novo Nordisk Inc. 800 Scudders Mill RoadPlainsboro, NJ 08536United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary...