Sun Pharma has received US FDA approval for its next-generation BLU-U® Blue Light Photodynamic Therapy (PDT) device, Model 4170E.
This device is designed to treat actinic keratosis (AK), a condition caused by prolonged sun exposure that can lead to skin cancer.
Key Highlights
- The new BLU-U® uses LED panels instead of fluorescent tubes
- It is compact, lighter, and easier to use in clinical settings
- Works with LEVULAN® KERASTICK® (aminolevulinic acid HCl) 20% solution
- Approved for AK on the face, scalp, and upper limbs
What Makes This Device Different?
- Takes up less space in dermatology clinics
- Five-panel design for better coverage
- Improved LED arrangement for consistent light delivery
- Enhanced patient comfort and handling for doctors
CEO Comment
Abhay Gandhi, CEO of Sun Pharma North America, said:
“We’re proud to receive FDA approval. This new device will offer better care to people living with actinic keratosis while maintaining the safety doctors trust.”
Approval Details
- Cleared under the FDA’s Real-Time Review Program
- Reflects the strength of Sun Pharma’s submission
- Shows continued collaboration between Sun Pharma and the FDA
Product Availability
The device will be available soon.
For purchase or clinical support, contact your Sun Pharma Specialty Dermatology representative.
Healthcare professionals can visit www.levulanhcp.com for more information.
About Actinic Keratosis (AK)
- Caused by long-term sun exposure
- Appears as rough, scaly skin patches
- Common on the face, scalp, arms, and hands
- Can progress to skin cancer if untreated
About LEVULAN KERASTICK + BLU-U
- FDA-approved PDT solution for AK
- Trusted by dermatologists for over 20 years
- Usually clears AK in one or two visits
- Combines 20% aminolevulinic acid with blue light therapy
About Sun Pharmaceutical Industries Limited
- Headquartered in Mumbai, India
- Largest pharmaceutical company in India
- Among top generic drug makers in the US and other markets
- Strong presence in dermatology, ophthalmology, and oncology
- Operates in over 100 countries with a global workforce
Visit www.sunpharma.com to learn more.