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Sun Pharma Shares Surge After US Regulator Accepts Drug Application

Shares of Sun Pharma surged 6.5 per cent on Wednesday after the US health regulator accepted a new drug application (NDA) for dry eye solution filed by the company's wholly-owned subsidiary.
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Sun Pharma stock climbed as much as 6.6 per cent to Rs 576 on the BSE on Wednesday
Sun Pharma stock climbed as much as 6.6 per cent to Rs 576 on the BSE on Wednesday
New Delhi: Sun Pharma shares surged more than 6.5 per cent on Wednesday after the US Food and Drug Administration (FDA) - the US health regulator - accepted a new drug application (NDA) for dry eye solution filed by the company's wholly-owned subsidiary. 

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

OTX-101 is now under review for approval by the USFDA, 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."

At 1:19 pm, shares in Sun Pharma were trading 6.1 per cent at Rs 573.55 apiece on the BSE, whose benchmark Sensex index was up 57 points at 34,068.

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