FDA Flags Issues in Galderma’s Botulinum Toxin Filing

FDA Flags Issues in Galderma's Botulinum Toxin Filing

While Galderma seeks to expand its range of injectable aesthetic treatments by gaining FDA approval for addressing crow’s feet and frown lines, the regulatory agency has identified certain manufacturing issues in its RelabotulinumtoxinA application, resulting in a complete response letter.

The concerns raised by the FDA specifically pertain to the chemistry, manufacturing, and controls (CMC) processes detailed in Galderma’s application. However, Galderma promptly acknowledged the necessary changes required to address this feedback.

Also Read: Hugel Resubmits BLA For Its Botulinum Toxin Letybo To The US FDA

It’s noteworthy that the FDA’s concerns are limited to the manufacturing aspect, and other aspects of the application have not been contested.

RelabotulinumtoxinA represents a “highly-active, ready-to-use” liquid formulation of botulinum toxin A, a product also marketed as Botox by AbbVie and as Jeuveau by Evolus. What sets this liquid formula apart is its departure from the conventional requirement of reconstituting the treatment from a powder form.

In a significant win during a phase 3 trial last summer, RelabotulinumtoxinA demonstrated impressive results. A remarkable 82.9% of recipients witnessed a two-grade or more improvement in the severity of frown lines within just one month of treatment, with nearly 40% noting a noticeable difference as early as day one.

Also Read: BOTOX Cosmetic Shows Promise For Neck And Lower Face Rejuvenation In Phase 3 Trial

Galderma is a company specializing in skincare solutions, particularly in the areas of dermal fillers, acne management, and various other skincare applications. This development underscores the company’s commitment to expanding its portfolio of aesthetic treatments, potentially offering consumers more options for addressing common skincare concerns.

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