Sun Pharma gets FDA approval for new device to treat skin disease

Sun Pharmaceutical Industries Limited announced that the U.S. 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%, 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.

"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."

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.

The LED BLU-U will be available for delivery in the near future. For details regarding availability, ordering, or implementation, please direct inquiries to your Sun Pharma Specialty Dermatology representative.