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73,852.94
+114.49
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Corporate Announcement
Security Code
532296
Company
Glenmark Pharmaceuticals Ltd
Exchange Received Time
22/06/2019 11:27:40
Exchange Disseminated Time
22/06/2019 11:27:49
Time Taken
00:00:09
FDA Issues Complete Response Letter For Ryaltris™ (Olopatadine Hydrochloride [665 Mcg] And Mometasone Furoate [25 Mcg]) |
6/22/2019 11:27:40 AM
We would like to inform you that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray. The CRL cites deficiencies in the Drug Master File (DMF) pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities.
The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris. We feel confident that we should be able to resolve these issues within the next 6 to 9 months. Glenmark Pharmaceuticals will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.
This is for your information and record please.
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