The USFDA has approved the company's fully-owned unit Glenmark Specialty SA (Switzerland)'s drug application (NDA) for Ryaltris, a fixed-dose (metered), prescription, combination nasal spray, according to Glenmark Pharmaceuticals.

 

The drug is used to treat the symptoms of seasonal allergic rhinitis in adults and children aged 12 and above, according to the company.

 

"The FDA's approval of Ryaltris is a significant step forward for Glenmark and demonstrates our commitment to bringing novel treatment alternatives to our key therapeutic areas," said Robert Crockart, Chief Commercial Officer of Glenmark Pharmaceuticals Limited.

 

He noted that now that the NDA has been approved, the business is looking forward to introducing this novel pharmaceutical to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms.

 

Hikma Specialty USA, Inc will sell and distribute Ryaltris in the United States as part of an exclusive licencing deal with Glenmark Specialty SA.

 

In Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan, Ryaltris has been approved and is on the market.

 

Glenmark completed the regulatory process in Europe in April 2021, allowing clearance in 17 EU and UK countries.

 

The pharmaceutical company has signed commercial partnerships with a number of companies throughout the world, including Menarini for the drug's commercialization in select EU regions and Bausch Health in Canada.

 

Health Canada is currently reviewing the product.