Sun Pharma Receives FDA Approval for Advanced BLU-U® PDT Illuminator for Actinic Keratosis

Sun Pharmaceutical Industries Limited has received approval from the U.S. Food and Drug Administration (FDA) for its latest innovation, the LED BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator. This approval introduces a next-generation device that offers a compact and user-friendly option for treating actinic keratoses (AK), a skin condition that can potentially lead to skin cancer. The new model features advanced light-emitting diode (LED) panels, replacing the older fluorescent tubes.

The LED BLU-U, used in conjunction with LEVULAN KERASTICK (aminolevulinic acid HCl) Topical Solution at 20% strength, targets minimally to moderately thick AKs on the face, scalp, or upper extremities. It retains the original model's treatment indications but introduces a more efficient design. The upgraded device is lighter, has a more flexible five-panel structure, and includes enhancements that aim to improve patient comfort and usability in dermatological practices.

Abhay Gandhi, CEO of Sun Pharma North America, expressed satisfaction with the FDA’s approval, highlighting the company's dedication to innovation in healthcare. Gandhi emphasized that this new LED BLU-U model promises enhanced efficiency and reliability, maintaining the trusted safety and effectiveness for which Sun Pharma is known among both healthcare professionals and patients dealing with AK.

The approval was granted under the FDA's Real-Time Review Program, underscoring the strength of Sun Pharma’s submission and its ongoing cooperation with the regulatory body. The LED BLU-U is expected to be available soon, with further details on ordering and implementation to be provided through Sun Pharma's Specialty Dermatology representatives.

Actinic keratosis (AK) is a condition marked by rough, dry, and scaly patches of skin that emerge from prolonged sun exposure. These lesions, varying in size from a pinhead to larger than a quarter, frequently develop on sun-exposed regions, including the face, scalp, arms, and hands. Without treatment, AK can progress to skin cancer, making effective treatment options crucial.

LEVULAN KERASTICK combined with BLU-U blue light photodynamic therapy is currently the only FDA-approved treatment specifically for actinic keratosis on the face, scalp, arms, and hands. This therapy has been trusted by dermatologists for over two decades, offering a safe and effective solution for eliminating AKs, often within one or two clinical visits.

Sun Pharmaceutical Industries Limited is a global leader in specialty generics, standing as India’s largest pharmaceutical company. It has a significant footprint in the U.S. and other emerging markets worldwide. The company’s diverse product offerings include dermatology, ophthalmology, and onco-dermatology, with its specialty portfolio contributing significantly to its revenues. Sun Pharma operates manufacturing facilities across six continents and boasts a diverse workforce from over 50 countries, reflecting its commitment to delivering high-quality medications in more than 100 countries globally.