Glenmark Pharma-led subsidiary receives USFDA approval for Ryaltris Nasal Spray

Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Limited

Highlights

Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company, today announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland) has received FDA approval on its New Drug Application (NDA) for Ryaltris.

Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company, today announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland) has received FDA approval on its New Drug Application (NDA) for Ryaltris.

Ryaltris is an innovative, fixed-dose (metered), aqueous suspension, prescription, combination drug product nasal spray for the treatment of symptoms of Seasonal Allergic Rhinitis in adults and pediatric patients 12 years of age and older in the United States.

“The FDA’s approval of Ryaltris™ represents a major milestone for Glenmark and clearly supports our efforts to bring innovative treatment options in our key therapeutic areas,” said Mr. Robert Crockart Chief Commercial Officer of Glenmark Pharmaceuticals Limited.

He added, “With this NDA approval, we look forward to bringing this new medicine to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms.”

Each unit of Ryaltris nasal spray contains 665 mcg of olopatadine hydrochloride, a histamine-1(H1)-receptor inhibitor, and 25 mcg of mometasone furoate, a corticosteroid. The safety and effectiveness of Ryaltris in pediatric patients younger than 12 years of age has not been established.

Ryaltris will be marketed and distributed in the United States (US) by Hikma Specialty U.S.A., Inc., as part of its exclusive licensing agreement with Glenmark Specialty S.A (Switzerland).

Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan. In April 2021, Glenmark concluded the DCP regulatory procedure in Europe, enabling approval in 17 countries across the EU and UK.

Glenmark has entered into commercial agreements with several partners around the world, including Menarini for the commercialization of Ryaltris in select EU markets, and with Bausch Health in Canada (where it is under review by Health Canada).

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