FDA warns of rare, life-threatening anaphylaxis with certain MS drug
Patients should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 911 if you experience symptoms of an anaphylactic reaction. Symptoms generally appear within one hour of injection and include wheezing or...Generic Drug Patient Education
Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. As 9 in 10 prescriptions filled are for generics, people may have questions about how they are the same as the name brand medications and why there is a cost...What Is the Approval Process for Generic Drugs?
Generic drugs are copies that one company makes of a brand-name drug that was developed by another company. Generally, generic drugs sell at lower prices, and it is in the public’s interest to get generic drugs to the market quickly. But, like any other...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...Drug Trials Snapshots: ANDEMBRY
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...Click To Verify Security & Validation
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