Little Spark Yet For Xelpros Amid New CRL
This article was originally published in Scrip
Sun Pharma Advanced Research Company (SPARC) has received a second complete response letter (CRL) from the FDA to its new drug application (NDA) for Xelpros (latanoprost BAK-free eyedrops), though the company claims this concerns "minor" labelling modifications.
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Xelpros may not be seen as a huge money-spinner, but its approval by the US FDA signals Sun Pharma's expanding interest in the US ophthalmology space. The clearance also potentially indicates that recent compliance issues at the company’s Halol site may not be all-encompassing.
Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative”. The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.