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FDA Approval For Xeomin: Regulatory Status of The Botulinum Toxin

David Fuller

Last Updated On: June 22, 2024

Did you know that Xeomin, often dubbed “naked botox,” is a powerful neuromodulator used to combat wrinkles and fine lines? With its purified form, Xeomin has gained popularity as an effective alternative to Botox injections, with many healthcare professionals and patients praising its efficacy.

Since its FDA approval in 2010, Xeomin has gained global recognition for cosmetic and therapeutic applications. Unlike other neurotoxins, Xeomin doesn’t contain accessory proteins, making it highly effective in treatments like smoothing wrinkles or treating muscle spasticity. 

In this article, we’ll delve deeper into the reasons for Xeomin’s FDA approval and examine real-life evidence of its effectiveness and potential side effects.

Key Takeaways

  • Xeomin got FDA approval in 2010 for treating conditions like cervical dystonia and certain types of facial wrinkles.
  • It works by blocking signals that cause muscles to tighten, which can help with muscle spasms and improve the look of wrinkles.
  • Even after getting FDA approval, doctors continue to study Xeomin to ensure its safety and effectiveness over time.
  • Some doctors use Xeomin for other issues not listed by the FDA, which shows its wide range of potential benefits.
  • Following FDA guidelines is essential when using Xeomin to ensure patients get treatment that’s known to be safe and effective.

About: Operating since 2016, Med Supply Solutions is known for being one of the industry’s top and trusted suppliers of cosmetic and viscosupplementation products. If you’re looking to buy Xeomin online, contact our sales department for more information.

Overview of Xeomin FDA Approval Process

Xeomin, FDA-approved since 2010, represents a significant advancement in medical treatments for specific conditions. Unlike its predecessors, Xeomin halts muscle contractions by blocking certain chemicals, offering a novel approach to treatment. Its FDA approval specifies its applications, setting it apart from similar treatments. 

Studies confirm Xeomin’s efficacy within prescribed doses, while a meticulous post-approval monitoring plan ensures safety. Moreover, Xeomin provides financial assistance, enhancing accessibility. As one of the few FDA-backed botulinum toxin products, Xeomin stands out for its therapeutic benefits in treating particular diseases, promising relief and improved quality of life for patients.

Key Milestones in Xeomin’s FDA Approval

Xeomin’s FDA approval opened new doors for treating various conditions focusing on precision and safety. Here’s how Xeomin made its way through the FDA’s rigorous process:

  1. Initial Research and Development: Scientists create Xeomin, focusing on its unique molecular profile. 
  2. Preclinical Trials: Before testing Xeomin on humans, researchers checked its safety in lab studies. 
  3. Phase I Clinical Trials: Small groups of volunteers first received Xeomin to assess its safety and determine the correct dosing.
  4. Phase II Clinical Trials: With success in early trials, more people tried Xeomin. The focus was on how well it worked for certain conditions, like cervical dystonia and frown lines.
  5. Phase III Clinical Trials: This phase involved even more participants, confirming Xeomin’s effectiveness and monitoring side effects closely.
  6. FDA Submission: After gathering all necessary data, the makers of Xeomin applied for FDA approval. 
  7. FDA Review: The agency reviewed all evidence about Xeomin’s safety and effectiveness. 
  8. Approval for Cervical Dystonia: The FDA first approved Xeomin specifically for treating adults with cervical dystonia, a key milestone showing that it could ease muscle tightness and pain.

Indications for Xeomin FDA Approval

Xeomin is a trusted treatment for various health issues, from smoothing facial wrinkles to treating cervical dystonia. Backed by solid research, Xeomin offers a safe and effective solution that relieves pain and enhances appearance. 

Doctors recommend Xeomin for its effectiveness in smoothing facial wrinkles, especially frown lines between the eyebrows, making patients look younger and more relaxed. This treatment prevents muscles from tightening excessively, resulting in less noticeable wrinkles. Patients appreciate Xeomin’s long-lasting results, which are typically noticeable within a week and last for months.

Safety and Efficacy of Xeomin

Doctors have seen good results from using Xeomin in their patients. They have found it safe and effective for treating certain medical conditions. This includes problems like cervical dystonia, which causes neck pain, abnormal head position, and wrinkles on the face.

Image courtesy of Richards Cosmetic Surgery

This patient, 49 years old, showing severe glabellar lines tried getting Xeomin injection for treatment. After 30 days, this was an amazing improvement in her appearance that made her a few years younger.

Image courtesy of Fade Aesthetics

14 days after this patient had been injected with 20 units of Xeomin, the frown lines in her forehead disappeared, making her look so much younger without the need for any surgeries.

Patients often report satisfaction with their outcomes after getting Xeomin for frown lines or under-eye bags. Studies show that the effects of Xeomin can last a long time, making it a reliable option for those looking to manage these issues.

Off-label Uses of Xeomin and Adherence to FDA-Approved Indications

Doctors are finding new uses for Xeomin beyond its FDA-approved treatments, such as addressing under-eye bags and masseter muscle issues. Even frown lines not covered by its original approvals are treated with Xeomin. This showcases its versatility and potential in clinical practice, requiring careful consideration and individualized treatment plans to ensure safety and efficacy.

Importance of Adhering to FDA-approved Indications in Clinical Practice

Using Xeomin for its FDA-approved indications, including Xeomin for under-eye bags, is key. Staying within these guidelines ensures patients receive a treatment backed by strong evidence for safety and effectiveness.

It also helps medical professionals avoid risks linked to non-approved uses. Sticking to what the FDA has approved means doctors can feel confident about the treatments they offer. They know they’re using Xeomin in ways that have been carefully tested and shown to work well.

Implications of Off-label Use for Medical Practitioners

Doctors sometimes use Xeomin off-label for conditions not specifically approved by the FDA. Off-label use doesn’t imply it’s unsafe, but doctors must exercise caution and explain their choice to patients. 

While off-label use expands treatment options, it also increases doctors’ responsibility to stay informed and use Xeomin appropriately. For instance, treating under-eye bags or masseter muscle issues with Xeomin can be helpful. Clear communication with patients about off-label use is essential.


The FDA approval of Xeomin for treating facial wrinkles and cervical dystonia underscores its safety and efficacy in clinical practice. Medical practitioners should leverage the approved indications and evidence-based practices to deliver optimal care while mindful of off-label use considerations. By staying informed and adhering to FDA-approved indications, practitioners can uphold the highest standards of patient care and safety.


1. What is Xeomin, and what does it do?

Xeomin, a purer alternative to Botox, effectively targets wrinkles and frown lines as a neurotoxin.

2. How long does Xeomin take to work, and how long does it last?

After receiving Xeomin injections, you may notice changes within a few days. Typically, it takes about a week to see the full effect. As for the duration, results vary from person to person, but you can expect to enjoy the benefits for several months.

3. Can I use Xeomin for my under-eye bags or jaw muscles?

Absolutely! Physicians use Xeomin to treat wrinkles, address puffy under-eye bags, and achieve a softer appearance in the jaw muscles (masseter). The goal is to enhance one’s overall appearance and confidence.

4. Is there anything I need to do after getting Xeomin?

Yes, there are essential post-treatment instructions to follow. Your doctor will provide detailed guidance on what steps to take after Xeomin reconstitution.


Everything You Need to Know About Xeomin, the Trendy Botox Alternative. Byrdie. Accessed May 3, 2024. https://www.byrdie.com/xeomin

Xeomin (incobotulinumtoxinA) FDA Approval History. Drugs.com. Accessed May 3, 2024. https://www.drugs.com/history/xeomin.html 



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