New Delhi: Sun Pharmaceutical Industries and its research arm Sun Pharma Advanced Research Company Ltd (SPARC) on Friday said it has got the US Food and Drug Administration’s (US FDA) approval for its new drug application of XELPROS, which is used to reduce open-angle glaucoma or ocular hypertension.
With this, Sun’s speciality ophthalmic portfolio in the US now features three approved products.
“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,” said a joint statement by Sun Pharma and SPARC.
The approval concerns Sun Pharma’s Halol (Gujarat) facility and negates recent concerns over the plant, which got six observations from US regulators last week, according to the statement.
SPARC is also eligible for milestone payments and royalties on commercialisation of XELPROS in the US, the statement added.
“This approval, coming less than one month after the approval of CEQUA (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing ophthalmic division and its commitment to serve the needs of patients with ocular disorders,” said Sun Pharma CEO North America Abhay Gandhi.
The approval was sought in June 2015. However, the company could not get the approval because of concerns raised by USFDA, with Sun pharma receiving a warning letter for Halol and future products approvals being withheld in December 2015. In June 2018, Halol was cleared by USFDA.
XELPROS will be commercialised in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd’s wholly-owned subsidiary.
Shares of Sun Pharma closed on Friday 2.35% higher at ₹665.10 apiece on BSE.
“Approval of XELPROS by USFDA is a significant milestone for SPARC. It is also a validation of our SMM technology, which helps to solubilise drugs that have limited or no solubility, thus eliminating the need for benzalkonium chloride,” said Anil Raghavan, the chief executive officer of SPARC.