Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Little Spark Yet For Xelpros Amid New CRL

This article was originally published in Scrip

Executive Summary

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.

You may also be interested in...



Xelpros Approval Adds Spark To Sun’s Site Too?

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 Site Out Of Compliance Rut, Could Add Some SPARC Too

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 CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'

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.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC029415

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel