USFDA to review allergic rhinitis drug of Glenmark Pharma
U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application for Ryaltris, an investigational fixed-dose combination nasal spray for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.
The nasal spray of Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg] is a combination of an antihistamine and a steroid and is Glenmark's leading respiratory pipeline candidate. The drug was formerly known as GSP 301 Nasal Spray. The US drug regulator has conditionally accepted Ryaltris FDA as the spray's brand name.
The company had previously submitted Ryaltris to the USFDA in May 2018, while in July, the company entered in a partnership with Seqirus to commercialize Ryaltris in Australia and New Zealand. It plans to explore commercial partnerships for Ryaltris in markets where it doesn’t have a direct presence.
Glenmark Pharma is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its geographical segments are India, United States, Latin America, Europe and Rest of the World (ROW).
In Wednesday’s trade, the stock has opened at Rs. 505.05 and at 11:13 am, the stock was quoting Rs. 586.75 per share.