Sun Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) for a new medical device designed to treat actinic keratoses (AK), a skin condition caused by prolonged sun exposure. AK is characterized by the appearance of red, rough patches on sun-exposed areas, and if left untreated, can develop into skin cancer. The condition often affects areas such as the face, scalp, and arms, and is a common concern for individuals who spend a significant amount of time outdoors.
The newly approved device is an upgraded version of the BLU-U Blue Light Photodynamic Therapy system, which has been enhanced with advanced LED technology. This new technology makes the device more compact and easier to operate compared to its predecessor, which used fluorescent tubes. The LED BLU-U device is used in conjunction with LEVULAN KERASTICK, a topical solution containing aminolevulinic acid, to treat mild to moderate AK. The combination of the device and topical solution provides a effective treatment option for individuals affected by this condition.
The FDA approval was granted through the Real-Time Review Program, which underscores the strength of Sun Pharma’s submission. The company believes that the new LED BLU-U device will enhance both user experience and treatment outcomes. The compact and easy-to-use design of the device is expected to improve patient comfort and compliance, while the advanced technology is likely to provide more effective treatment results. With the approval of this new device, Sun Pharma is well-positioned to provide a valuable treatment option for individuals affected by AK, and to help prevent the development of skin cancer.
The approval of the new LED BLU-U device is a significant milestone for Sun Pharma, and demonstrates the company’s commitment to developing innovative treatments for skin conditions. The device is expected to be a valuable addition to the company’s portfolio of dermatology products, and will provide healthcare professionals with a new option for treating AK. Overall, the approval of the new LED BLU-U device is a positive development for individuals affected by AK, and highlights the ongoing efforts to develop effective treatments for skin conditions.