Sunday, March 16, 2025 | 02:40 AM ISTहिंदी में पढें
Business Standard
Notification Icon
userprofile IconSearch

USFDA accepts Sun Pharma's new eye drug application

Shares of Sun Pharma were up 5.75 per cent at Rs 571.55 on the BSE

Sun Pharma, generic drugs, R&D, India

Sun Pharmaceutical Managing Director Dilip Shanghvi (centre) at the company's headquarters in Mumbai

Press Trust of India New Delhi
The US health regulator has accepted a new drug application (NDA) for an ophthalmic solution filed by Sun Pharma's wholly-owned subsidiary, the drugmaker said on Wednesday.

"The US Food and Drug Administration (USFDA) has accepted a new drug application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution)," Sun Pharmaceutical Industries said in a BSE filing.

"OTX-101 is now under review for approval by the US FDA, marking an important developmental milestone for Sun Pharma's dry eye candidate," it added.

Sun Pharma MD Dilip Shanghvi said: "OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing under-served and dynamic dry eye market. When approved, it will be a milestone for millions of dry eye patients across the globe that are yet to find relief for their condition."
 

OTX-101 is being developed for global markets.

Sun Pharma said that post the USFDA approval, OTX-101 will be commercialised in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma's wholly owned subsidiary, which markets BromSite to eyecare practitioners across the US.

Shares of Sun Pharma were up 5.75 per cent at Rs 571.55 on the BSE.
Topics : Sun Pharma

Don't miss the most important news and views of the day. Get them on our Telegram channel

First Published: Dec 27 2017 | 12:34 PM IST

Explore News