As of 2024, the U.S. Food and Drug Administration (FDA) has approved over 20 injectable products for facial rejuvenation, including popular hyaluronic acid fillers and botulinum toxin formulations. This extensive approval process ensures standardized efficacy and minimizes adverse events, which are crucial for patient safety in aesthetic practice.
Despite the rigorous regulatory scrutiny, clinicians are increasingly considering Innotox, a Korean botulinum toxin known for its ready-to-use formulation, high purity, and stable potency. However, understanding Innotox’s approval status and labeled indications is essential for ensuring compliance and optimizing patient safety.
In this article, we will review Innotox’s FDA approval status, examine its approved indications and core clinical evidence, and provide practical guidance for its safe and effective administration in aesthetic practice.
Key Takeaways
- Innotox remains unapproved by the FDA in the United States but has received regulatory clearance in South Korea and other regions, showcasing its efficacy and safety in aesthetic treatments.
- Innotox is the world’s first ready-to-use liquid formulation of botulinum toxin type A, offering a convenient and consistent option for practitioners, eliminating the need for reconstitution.
- Medytox has not yet filed an Investigational New Drug (IND) application or Biologics License Application (BLA) in the U.S., which has delayed the FDA approval process for Innotox.
- Clinical trials in South Korea demonstrated that Innotox is comparable to Botox in terms of safety and efficacy, particularly for glabellar line reduction.
- CE certification allows Innotox to be sold and used in several countries, including Germany, France, Italy, Spain, and parts of the Middle East and Latin America.
- Innotox faces challenges in the U.S. market due to legal disputes with Daewoong and issues related to the integrity of safety data, which have slowed its FDA approval process.
- The eventual approval of Innotox by the FDA could position it as a significant competitor to other established botulinum toxin products in the U.S. market.
About: Medica Depot is your trusted all-in-one supplier, offering a range of high-quality medical injectables and supplies. If you’re looking to buy Innotox, contact Medica Depot’s sales representatives and they will guide you on how to do so. Whether for health professionals, plastic surgeons, dermatologists, licensed estheticians, or other specialists, we can offer genuine, brand-name products you may need. With Medica Depot, we prioritize serving you better to improve the patient’s quality of life.
The Regulatory Path of Innotox from South Korea to the U.S.
In addition to common questions like “How long does Innotox last after opening?” or “How to inject Innotox?”, practitioners may also wonder about Innotox’s FDA approval status. Regulatory clearances are essential for expanding a brand’s reach into global markets. These clearances allow products to cater to a broader audience across various regions.
In 2013, South Korea’s Ministry of Food and Drug Safety (MFDS) approved Innotox as the world’s first ready-to-use liquid formulation of botulinum toxin type A. This approval followed rigorous safety and efficacy studies conducted in accordance with Korean regulations.
However, each region requires local authorities to review clinical data before allowing injectables to enter their markets. Innotox demonstrated comparable wrinkle reduction to traditional powder-based toxins, which eases its market entry and appeals to patients who prioritize convenience and efficiency in addressing their aesthetic concerns.
That said, Medytox, the manufacturer of Innotox, has yet to undergo the FDA approval process in the U.S. Aside from the Innotox before and after photos and other reviews, Medytox must conduct more clinical trials to demonstrate Innotox’s safety and efficacy to U.S. regulators.
Current FDA Status and Clinical Trial Progress for Innotox
Currently, Innotox remains unapproved by the FDA and can only be used in the United States within FDA-sanctioned clinical trials. Medytox has not yet filed an Investigational New Drug (IND) application or a Biologics License Application (BLA), meaning that approval could be delayed for some time.
Although Medytox partnered with Evolus, no formal U.S. trial registrations or regulatory filings are publicly available at this time.
In contrast, South Korea’s MFDS cleared Innotox after Phase I–III studies, demonstrating safety and efficacy comparable to onabotulinumtoxinA for glabellar line reduction. These studies also showed significant wrinkle improvement at 16 weeks, adding credibility to Innotox’s clinical profile.
These robust international data will support future U.S. trial designs and any eventual FDA submission.
CE Certification and Global Use of Innotox Outside the U.S.
CE marking proves that a medical device meets the EU’s safety, performance, and environmental requirements under Regulation (EU) 2017/745. Manufacturers work with a notified body to assess conformity, after which they can affix the CE mark to their products.
Innotox distributors have secured CE certification, enabling clinics to offer Innotox under the same stringent quality standards that apply to other CE-marked devices. Furthermore, distributors and clinics maintain CE status by:
- Keeping detailed technical dossiers on file
- Undergoing scheduled audits
- Updating documentation with any product or process changes
Mutual Recognition Agreements extend CE acceptance into Turkey and Switzerland via EFTA frameworks. In regions where CE marking is not mandatory, such as parts of Latin America and the Middle East, authorities review CE conformity evidence alongside local regulatory submissions, enabling Innotox to reach markets outside the United States.
Innotox is available in multiple countries, including:
- Germany, France, Italy, Spain, and the UK for glabellar lines, crow’s feet, and hyperhidrosis
- Select countries in Latin America
- Several markets across the Middle East
Until Innotox is FDA-approved, practitioners will continue to rely on approved neuromodulators like Botox, Dysport, Jeuveau, and Xeomin for treatments in the U.S..
Legal and Commercial Developments Impacting Innotox Approval
In December 2020, South Korea’s MFDS ordered Medytox to halt all Innotox production and sales. This came after the alleged falsification of key approval documents. Medytox filed a suit to lift the ban and nullify the MFDS order. It then led to uncertainty in Innotox’s domestic market and drew scrutiny from international regulators and investors.
In the United States, Medytox’s plan to partner with Evolus and rebrand Innotox as “DTAB” stalled due to intellectual property disputes with Daewoong. Daewoong petitioned the FDA to investigate the integrity of Innotox’s safety data. As a result, Medytox has yet to file an IND or BLA application, further delaying approval.
Regulators in each jurisdiction conduct conformity assessments and routine audits to verify Innotox’s quality and safety. These reflect both the product’s broad appeal and the complex, region-specific regulations that companies must meet to expand globally.
Conclusion
The FDA approval of Innotox remains pending in the United States. However, the product’s success in South Korea and other global markets highlights its efficacy and safety in aesthetic treatments. Medytox continues to build upon its international clinical data, which will support the eventual FDA submission and approval process.
While Innotox remains unapproved by the FDA in the U.S., its CE certification and availability in multiple countries worldwide demonstrate its global appeal and potential. Practitioners must continue to rely on approved neuromodulators for U.S. treatments, but Innotox’s future in the U.S. market looks promising as more studies are conducted and regulatory hurdles are cleared.
FAQs
1. What is Innotox?
Innotox is a ready-to-use injectable formulation of botulinum toxin type A, known for its high purity and stability.
2. Is Innotox approved by the FDA?
No, Innotox is currently unapproved by the FDA and can only be used in the United States within FDA-sanctioned clinical trials.
3. Where is Innotox available internationally?
Innotox has CE certification and is available in countries such as Germany, France, Italy, Spain, and parts of Latin America and the Middle East.
References
Center for Devices and Radiological Health. Aesthetic (Cosmetic) Devices. FDA. Published December 7, 2022. Accessed July 18, 2025. https://www.fda.gov/medical-devices/products-and-medical-procedures/aesthetic-cosmetic-devices
Lee HS. Daewoong to ask FDA to investigate Medytox’s BTX. Korea Biomedical Review. Published January 29, 2021. Accessed July 18, 2025. https://www.koreabiomed.com/news/articleView.html?idxno=10320
