General Announcement::FDA Issues Complete Response Letter for Ryaltris - olopatadine hydrochloride and mometasone furoate

Issuer & Securities

Issuer/ Manager
GLENMARK PHARMACEUTICALS LIMITED
Securities
GLENMARK PH US$200M4.5%210802 - XS1456577334 - 4N4B
GLENMARK PHARM US$170M2%220628 - XS1426780125 - 4G8B
Stapled Security
No

Announcement Details

Announcement Title
General Announcement
Date &Time of Broadcast
22-Jun-2019 14:22:30
Status
New
Announcement Sub Title
FDA Issues Complete Response Letter for Ryaltris - olopatadine hydrochloride and mometasone furoate
Announcement Reference
SG190622OTHRQB9V
Submitted By (Co./ Ind. Name)
Glenmark Pharmaceuticals Limited
Designation
Company Secretary & Compliance Officer
Description (Please provide a detailed description of the event in the box below)
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.

Attachments

CA_SGX_22062019_signed.pdf
Total size =166K