FDA issues Complete Response Letter for Ryaltris

25 June 2019

The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Ryaltris (olopatadine hydrochloride [665mcg] and mometasone furoate [25mcg]), nasal spray, a treatment for seasonal allergic rhinitis (SAR), India’s Glenmark Pharmaceuticals (BSE: 532296) revealed in a Bombay Stock Exchange filing.

The CRL cites deficiencies in the Drug Master File (DMF) relating 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 NDA 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,” said Glenmark.

Shares of Glenmark Pharmaceuticals hit a 52-week low of 467 rupees, down 7% on the BSE in the early morning trade on Monday after the revelation. The stock was trading at its lowest level since April 4, 2013.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK