Sun Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration (FDA) has granted premarket approval application (PMA) approval of the next generation of BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator which features light emitting diode light (LED) panels as a replacement for the previous model's fluorescent tubes.

The new model (LED BLU-U) in combination with LEVULAN KERASTICK (aminolevulinic acid HCl) Topical Solution, 20 percent, 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 company said in a statement.

Abhay Gandhi, Sun Pharma North America CEO, said, “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. 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."

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.