Sun Pharmaceutical Industries Ltd. has received approval from the US Food and Drug Administration (USFDA) for an updated label for its medication UNLOXCYT (tretinoin), which is used to treat a rare skin condition called Cutaneous Squamous Cell Carcinoma (CSCC) in patients with advanced renal cell carcinoma (RCC). The updated label includes long-term efficacy data, demonstrating the treatment’s effectiveness in preventing the progression of CSCC.
UNLOXCYT is a topical formulation of tretinoin, a retinoid that has been shown to inhibit the growth of cancer cells. The medication is specifically designed to treat CSCC, a type of skin cancer that can occur in patients with advanced RCC. The condition is often aggressive and can lead to significant morbidity and mortality if left untreated.
The updated label includes data from a long-term study that evaluated the efficacy of UNLOXCYT in preventing the progression of CSCC in patients with advanced RCC. The study demonstrated that treatment with UNLOXCYT significantly reduced the risk of CSCC progression compared to placebo. The data also showed that UNLOXCYT was well-tolerated, with a safety profile consistent with previous studies.
The approval of the updated label is a significant milestone for Sun Pharma, as it provides healthcare providers with additional confidence in the long-term efficacy of UNLOXCYT in treating CSCC. The company believes that the updated label will help to increase awareness and adoption of the medication among healthcare providers and patients.
The USFDA approval is also a testament to Sun Pharma’s commitment to developing innovative treatments for rare and debilitating diseases. The company has a strong portfolio of specialty and generic products, and is dedicated to improving the lives of patients around the world.
In a statement, a spokesperson for Sun Pharma said, “We are pleased to receive USFDA approval for the updated UNLOXCYT label, which includes long-term efficacy data demonstrating the treatment’s effectiveness in preventing the progression of CSCC. This approval is a significant milestone for our company, and we believe it will help to increase awareness and adoption of UNLOXCYT among healthcare providers and patients.” The updated label is expected to be available in the US market shortly.