Croma-Pharma GmbH Celebrates FDA Approval of Obagi saypha® MagIQ™ in the United States
LONDON, Sept. 10, 2025 /PRNewswire/ -- Croma-Pharma GmbH, a global leader in minimally invasive aesthetic medicine, proudly announces that the U.S. Food and Drug Administration (FDA) has approved Obagi saypha® MagIQ™ injectable hyaluronic acid (HA) gel – the first intradermal filler product in the Obagi saypha® collection – for commercial use in the U.S. market.
Developed by Croma-Pharma and brought to the U.S. through its strategic partner Waldencast plc under the Obagi Medical brand, this FDA approval marks a significant milestone in Croma's global expansion strategy. The commercial launch is planned for 2026 and represents the beginning of a multi-product U.S. rollout that will also include saypha® ChIQ™ and additional innovations, pending further regulatory clearance.
"We are extremely proud to bring our advanced HA technology to the United States through our collaboration with Waldencast and Obagi Medical," said Andreas Prinz, Chief Executive Officer of Croma-Pharma GmbH. "This milestone reinforces our legacy of innovation and scientific excellence in aesthetic medicine. With more than 110 million syringes produced and a presence in over 80 markets, Croma is committed to delivering high-performing products that meet the expectations of healthcare professionals and patients worldwide."
Obagi saypha® MagIQ™ is powered by Croma's U.S. pivotal study for nasolabial fold (NLF) correction including 270 patients and confirming non-inferiority versus the FDA approved control product, meeting the primary performance endpoint with key secondary endpoints further reinforcing its effectiveness and safety profile. The trial included all Fitzpatrick Skin Types demonstrating the product's effectiveness and safety across a representative population.
"This FDA approval validates the safety and performance of our saypha® filler technology and is the result of our commitment to deliver scientific data based aesthetic solutions for medical doctors" added Prinz. "We believe this will lay the foundation for long-term success in the world's most significant aesthetic market."," added Prinz.
This launch marks a new chapter in the relationship between Croma-Pharma and Obagi Medical, bringing together a legacy of European HA innovation with one of the most trusted names in U.S. medical-grade skincare.
As Croma continues to expand its presence globally, the company remains focused on portfolio innovation across HA fillers, biostimulators, PDO threads, and botulinum toxin – empowering aesthetic physicians with the tools they need to deliver holistic treatment outcomes.
About Croma-Pharma GmbH
Croma-Pharma GmbH is a family-owned global player in the minimally invasive aesthetics market, headquartered in Leobendorf, Austria. The company specializes in the industrial production of hyaluronic acid syringes and distributes its own aesthetic portfolio, including botulinum toxin, fillers, PDO threads, PRP, and skincare technologies, in more than 80 markets worldwide.
About Waldencast
Founded by Michel Brousset and Hind Sebti, Waldencast's ambition is to build a global best-in-class beauty and wellness operating platform by developing, acquiring, accelerating, and scaling conscious, high-growth purpose-driven brands. Waldencast's vision is fundamentally underpinned by its brand-led business model that ensures proximity to its customers, business agility, and market responsiveness, while maintaining each brand's distinct DNA. The first step in realizing its vision was the business combination with Obagi Medical and Milk Makeup. As part of the Waldencast platform, its brands will benefit from the operational scale of a multi-brand platform; the expertise in managing global beauty brands at scale; a balanced portfolio to mitigate category fluctuations; asset light efficiency; and the market responsiveness and speed of entrepreneurial indie brands. For more information please visit: https://ir.waldencast.com/.
About Obagi Medical
Obagi Medical is an industry-leading, advanced skincare line rooted in research and skin biology, with a legacy of 35+ years of experience. Initially known for its leadership in the treatment of hyperpigmentation with the Obagi Nu-Derm® System, Obagi Medical products are designed to address a variety of skin concerns, including premature aging, photodamage, skin discoloration, acne, and sun damage. As the fastest-growing professional skincare brand in the U.S. in 2024,2 Obagi Medical empowers individuals to achieve healthy, beautiful skin. More information about Obagi Medical is available on the brand's website, https://www.obagi.com.
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