Glenmark Pharmaceuticals announced that the Ministry of Health of the Russian Federation has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis, and the company expects to launch the nasal spray in Russia in the first quarter of fiscal year 2021-22.
Glenmark Pharmaceuticals Senior VP, Russia & CIS region, Csaba Kantor said, “Glenmark has built strong capabilities in the area of respiratory medicine and is among the leading players in this therapy area across several markets globally. Russia is one of the key markets for us and we are consistently looking to expand our product portfolio. We are delighted to receive an approval for Ryaltris nasal spray in the Russian market. This new innovative addition to our portfolio is yet another major step in strengthening Glenmark’s respiratory focus in Russia and the CIS region. Glenmark has a strong established presence in Russia for over 30 years, which will enable us to lead the commercialization of this product in the country. We look forward to being able to make this innovative product available to patients in Russia as soon as possible.”
Ryaltris is approved in several other countries, including Australia, South Korea, Ukraine, and Uzbekistan. In the US, Glenmark received a complete response letter to its NDA for Ryaltris in June 2019; the company says that the NDA is currently under review. Hikma Pharmaceuticals acquired US rights Ryaltris in February 2020, and Menarini aquired European rights to the nasal spray in December 2020.
Read the Glenmark Pharmaceuticals press release.