RyaltrisTreatment for Allergic Rhinitis
FDA Issues Complete Response Letter for Ryaltris NDA
June 25, 2019 -- Glenmark Pharma on Saturday said the US Food and Drug Administration (USFDA) 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 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," the company said in a regulatory filing.
Glenmark Pharma said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.
Source: Glenmark Pharma
Posted: June 2019
- Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018 - November 15, 2018
- Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis - May 21, 2018
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive