Ryaltris Gains Pediatric Indication for Seasonal Allergic Rhinitis
On July 21, 2026, the US Food and Drug Administration (FDA) expanded Glenmark Specialty’s Ryaltris® (olopatadine/mometasone) nasal spray approval to include pediatric patients aged six years and older for the treatment of symptoms of seasonal allergic rhinitis (SAR). Initially approved in 2022 for adults and pediatric patients aged 12 years and older, Ryaltris is a fixed-dose combination nasal spray that combines an antihistamine, 665mg olopatadine, and a corticosteroid, 25mg mometasone, in a single spray, providing dual-action symptom control. Approval was supported by a phase III randomized, double-blind, placebo-controlled study of 446 children aged six to 11 years, which demonstrated improved nasal symptoms versus placebo and was generally well tolerated during the 14-day treatment period. The recommended dose is two sprays in each nostril twice daily for adults and patients aged 12 years and older, and one spray in each nostril twice daily for children aged six to 11 years. Ryaltris is for intranasal use only and requires priming before first use and after extended periods of nonuse. Here is the updated prescribing information.
Generic Januvia XR Launches
Par Health announced the launch of the first generic version of Janumet XR® (sitagliptin and metformin hydrochloride extended-release) tablets on July 24, 2026. Janumet XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This launch follows the recent availability of generic Januvia and Janumet in May and June 2026. According to IQVIA data cited by the company, branded Janumet XR generated approximately $269.9 million in US sales during the 12 months ending May 2026. Additional entrants are expected to launch in late November 2026.
Furosemide Rapid At-Home Autoinjector Approved
On July 24, 2026, the FDA approved Furoscix ReadyFlow™ (furosemide injection – MannKind Corporation) for the treatment of edema (fluid overload) in adults with heart failure or chronic kidney disease. Furoscix ReadyFlow builds on decades of clinical experience with furosemide, a loop diuretic first approved in the 1960s and follows the 2022 approval of the subcutaneous (SC) Furoscix on-body infusor, which delivers therapy over five hours. Furoscix Readyflow is a new autoinjector designed for SC self-administration outside the hospital setting and delivers a dose in less than 10 seconds. Approval was supported by data demonstrating intravenous (IV)-equivalent exposure and diuretic effect compared with IV furosemide, potentially allowing earlier intervention for worsening fluid overload. According to the company, symptom relief may begin within an hour. The recommended dose is a single 80mg SC injection via a prefilled autoinjector. It is not intended for chronic use and should be replaced with oral diuretics as soon as practical. Furoscix On-body infusor remains available and Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026. Here is the updated prescribing information.
Recall
Cetirizine Recall Issued Due to Ranitidine Cross-Contamination
On July 18, 2026, Unique Pharmaceutical Laboratories announced a voluntary consumer-level recall of four lots of cetirizine hydrochloride tablets 5mg due to cross-contamination with ranitidine during manufacturing. The issue was identified after a product complaint from a pharmacy technician who observed tablets with red spots and discoloration while counting and dispensing the medication. Cetirizine is an over-the-counter antihistamine used to treat allergy symptoms and affected tablets may contain ranitidine, a H2 receptor antagonist used for acid-related conditions. Patients with hypersensitivity to ranitidine who take the affected tablets may be at risk for serious allergic reactions, including anaphylaxis. No adverse events related to the recall have been reported to date. Patients and providers are encouraged to report adverse events or product quality concerns to FDA MedWatch. The FDA recall notice is available here.