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Home » Glenmark Draws Complete Response Letter for Allergy Spray
Glenmark Draws Complete Response Letter for Allergy Spray
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July 9, 2019
Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form of a complete response letter.
The regulators cited deficiencies in the drug master file for one of Ryaltris’ (olopatadine hyrdrocholdoride and mometasone furoate) active ingredients, the Mumbai, India-based drugmaker said.
“We feel confident that we should be able to resolve these issues within the next six to nine months,” said Glenmark’s Secretary and Compliance Officer Harish Kuber.
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