The new model (LED BLU-U) in combination with LEVULAN KERASTICK (aminolevulinic acid HCl) topical solution, 20%, is indicated for the treatment of minimally to moderately thick actinic keratoses (AK) of the face, scalp, or upper extremities.
The new LED BLU-U is approved for the same indications as the previous model but takes up less space in a dermatologist’s office, and has a more flexible five-panel shape, improved LED arrangement, lighter weight, and other updated functions that may increase patient comfort and ease of use.
The approval of LED BLU-U was granted under FDA’s Real-Time Review Program, reflecting the robustness of the submission and Sun Pharma’s continued collaboration with the Agency.
“We are pleased to receive the FDA’s approval of LED BLU-U and look forward to seeing the positive impact this next generation device will have for those living with actinic keratosis,” said Abhay Gandhi, Sun Pharma North America CEO. “As a company committed to innovation, we are confident that this new LED BLU-U model will provide improved efficiency and reliability while maintaining the safety and efficacy that healthcare professionals and people with AKs have come to trust from Sun Pharma.”
Sun Pharmaceuticals Industries is a leading global pharmaceutical company with a specialty and generic presence and India's top pharma company.
The pharma major’s consolidated net profit increased 15.04% to Rs 2,903.38 crore on a 10.46% rise in revenue from operations to Rs 13,675.46 crore in Q3 FY25 over Q3 FY24.