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

The company says that the new device is more compact and easier to use than its predecessor

Pharma major Sun Pharmaceutical Industries on Friday said it has received approval from the US Food and Drug Administration (USFDA) for a new medical device that treats a skin disease called actinic keratoses. According to the official website of US National Center for Biotechnology Information (NCBI), the disease is “often associated with chronic sun exposure, (and) individuals with actinic keratosis may present with irregular, red, scaly papules or plaques on sun-exposed regions of the body".

 

It also states that it is important to treat the disease in its early stages as delay in the treatment can lead to skin cancer.

 

The new device from Sun Pharma treats the disease in combination with LEVULAN® KERASTICK®,  a liquid that contains a substance called aminolevulinic acid and is designed for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.

 

The approved device is an upgraded system of BLU-U Blue Light Photodynamic Therapy (PDT) and uses LED technology for treatment whereas the older version used fluorescent tubes to produce blue light.

 

Sun Pharma said that the approval of the device was granted under the USFDA’s Real-Time Review Program, reflecting the robustness of the submission and Sun Pharma’s continued collaboration with the agency.

 

The company added that the new device is more compact and easier to use than its predecessor.

 

“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, chief executive offier at Sun Pharma (North America).

 

“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,” Gandhi added.