Glenmark Pharmaceuticals has revealed that the FDA issued a complete response letter to the company’s NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray. The agency accepted the NDA for Ryaltris in August 2018 with a PDUFA date of March 21, 2019.
According to Glenmark, the CRL references issues related to the drug master file for one of the APIs and manufacturing facilities but does not cite any issues related to clinical data. The company added, “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.”
The company also announced that its Brazilian subsidiary Glenmark
Farmacêutica has finalized a deal with Novartis for commercialization and distribution rights to the Seebri, Onbrize, and Ultibro Breezhaler DPIs for the treatment of COPD in Brazil, effective July 1, 2019.
Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha commented, “We are pleased to partner with Novartis in Brazil. This arrangement with a leading global pharmaceutical company will strengthen our respiratory franchise in Brazil. This partnership is in line with our vision to expand our respiratory product offerings for patients and prescribers in Brazil and further consolidate our position in this segment.”
Read the Glenmark Pharmaceuticals announcement regarding Ryaltris.
Read the Glenmark Pharmaceuticals press release on Brazilian rights to Breezhaler DPIs.
