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Sun Pharma gets FDA green light for Xelpros

Sun Pharmaceutical Industries and Sun Pharma Advanced Research have received the Food and Drug Administration’s approval for Xelpros (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension.

Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. Xelpros is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology, according to the company.

“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” Sun Pharma North America's CEO, Abhay Gandhi said. “This approval, coming less than one month following the approval of Cequa (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”

Xelpros will be commercialized in the United States by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries’s wholly owned subsidiary.

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