Products News for August 2025

RX Products

Zoster Vaccine Recombinant, Adjuvanted (Shingrix)

From: GSK

FDA officials approved a prefilled syringe presentation of the zoster vaccine recombinant, adjuvanted (RZV, Shingrix; GSK) for the prevention of herpes zoster, commonly known as shingles. The approval simplifies the vaccination process by removing the need to reconstitute separate vials before administration. RZV is a nonlive vaccine designed to prevent shingles in adults 50 years and older by combining the glycoprotein E antigen with the AS01B adjuvant system, which could help improve the immune response in older adults. It is also approved to treat individuals 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression.

For more information: shingrix.com

Insulin Aspart-xjhz (Kirsty)

From: Biocon

The FDA approved insulin aspart-xjhz (Kirsty; Biocon Sdn Bhd) as the first interchangeable biosimilar insulin product to insulin aspart (NovoLog; Novo Nordisk), marking a significant milestone in improving access to insulin therapies for patients with diabetes. Insulin aspart-xjhz is a rapid-acting human insulin analogue that is indicated to improve glycemic control in adults and pediatric patients with diabetes. It will be available as a 3-mL single-patientuse prefilled pen and a 10-mL multiple-dose vial, both administered subcutaneously. The vial formulation may also be used via insulin pump or intravenous infusion, offering flexibility for patients and providers.

For more information: biocon.com

OTC Product

Big 10 Probiotic

From: Olly

Olly is stepping into the gut health spotlight with the launch of its Big 10 Probiotic product. The Big 10 Probiotic contains a blend of ingredients such as Lactobacillus plantarum, 2 strains of Lactobacillus, and Bifidobacterium animalis, and offers the convenience of being shelf-stable with no refrigeration required. The formula was developed using a benefits-driven, data-first approach, with ingredients selected based on evidence demonstrating their roles in digestive balance, immune support, gut biodiversity, and stress resilience.

For more information: olly.com

Generic Product

Rivaroxaban

Compare with: Xarelto

From: Taro Pharmaceuticals

The first generic version of rivaroxaban 2.5 mg received FDA approval for use in adults with coronary artery disease and peripheral artery disease, aimed at reducing major cardiovascular and thrombotic events. This low-dose oral anticoagulant’s approval was supported by the pivotal phase 3 COMPASS (NCT01776424) and VOYAGER PAD (NCT02504216) trials, which demonstrated a statistically significant reduction in major adverse cardiovascular events when rivaroxaban 2.5 mg was added to aspirin, compared with aspirin alone. With this generic, patients at elevated cardiovascular risk can access a proven, guideline-supported therapy at lower cost, increasing treatment affordability and potentially improving adherence.

For more information: taro.com