Sun Pharmaceutical Industries Limited reported that the U.S. Food and Drug Administration (FDA) has now approved premarket approval application (PMA) for the new, next generation BLU-U PDT Illuminator equipped with LED panels instead of fluorescent tubes used in the earlier model.
LED BLU-U has been approved, with LEVULAN KERASTICK, for handling actinic keratoses on the face, head or arms, depending on how thick they are.
The new LED BLU-U can still be used for the same medical conditions as the previous model, but it needs less space in a dermatology practice and is easier to move due to its improved five-panel shape, better LEDs, lighter weight and other recent upgrades.
"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 Pharma’s submission to the Real-Time Review Program was considered strong enough by FDA to approve LED BLU-U.
Shipments of the LED BLU-U will be made soon. Please register your request or ask for support, with your Sun Pharma Specialty Dermatology representative.
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