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14-Sep2018

Sun Pharma, SPARC get approval from USFDA for NDA of XELPROS

Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company (SPARC) have received approval from US Food and Drug Administration (USFDA) for the New Drug Application (NDA) of 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. This approval is from Sun Pharma's Halol in Gujarat facility.

The company in-licensed XELPROS from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of XELPROS in the US.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.


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