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8 months ago
BRIEF-Sun Pharma Advanced Research gets complete response letter from FDA for Xelpros
December 22, 2016 / 3:41 AM / 8 months ago

BRIEF-Sun Pharma Advanced Research gets complete response letter from FDA for Xelpros

Dec 22 (Reuters) - Sun Pharma Advanced Research Company Ltd

* Update on Xelpros (latanoprost ophthalmic emulsion) NDA

* Says co got complete response letter from FDA for Xelpros

* Says CRL references recent FDA inspection at Sun Pharma Industries' halol unit

* No requirement of additional data from the USFDA on CRL

* Says CRL indicates satisfactory resolutions of deficiencies identified during inspection is needed for approval of Xelpros Source text: bit.ly/2i2Yr2x Further company coverage:

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