Sun Pharma and SPARC's XELPROS gets USFDA approval
New Delhi: Sun Pharma and it is research arm Sun Pharma Advanced Research Company Ltd (SPARC) said the US Food and Drug Administration (USFDA) has approved its new drug application of XELPROS, used to reduce open-angle glaucoma or ocular hypertension.
"This approval is from Sun Pharma's Halol (Gujarat) facility. Sun Pharma in-licensed XELPROS from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC," Sun Pharma and SPARC said in a joint statement. After the Halol facility warning, USFDA gets first approval.
Sun Pharma gets 6 observations by USFDA for its Halol facility
SPARC is also eligible for milestone payments and royalties on the commercialisation of XELPROS in the US, it added.
"This approval, coming less than one month following the approval of CEQUA(cyclosporine ophthalmic solution) 0.09 per cent, reaffirms the strength of Sun Pharma's fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders," Sun Pharma CEO North America Abhay Gandhi said.
XELPROS will be commercialised in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd's wholly-owned subsidiary.
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