January 2026 Product Updates

Rx Products

Flow FL-100

From: Flow Neuroscience

The FDA has approved the Flow FL-100, the first at-home transcranial direct current stimulation medical device cleared in the US for treating moderate to severe depression in adults, either alone or with medication. The decision is supported by results from the Empower study, a remote, double-blind, placebo-controlled trial with 174 patients that showed statistically significant improvements in Hamilton Depression Rating Scale scores with active treatment. Already available in several countries since 2019, the headset is designed to address depression by directly targeting brain function.

For more information: https://www.flowneuroscience.com/

Omalizumab-igec (Omlyclo)

From: Celltrion USA

The FDA approved a new 300-mg/2-mL prefilled syringe of omalizumab-igec, expanding options for the first interchangeable biosimilar of omalizumab (Xolair; Genentech, Inc/Novartis Pharmaceuticals Corporation). Used to treat several allergic and inflammatory conditions, the higher-dose presentation is intended to reduce injection burden and increase convenience. The approval builds on evidence from a large phase 3 trial showing that omalizumab-igec matched omalizumab in efficacy, safety, and durability across multiple dosing periods, with similar improvements in itch severity, urticaria activity, and rescue antihistamine use. According to a news release from the company, the new option broadens flexibility and access for patients who rely on biologic therapy.

For more information: https://www.celltrionusa.com/

OTC Product

Aspirina

From: Bayer

Bayer has introduced Aspirina—its No. 1 pain relief option in Mexico—to the US market, offering a familiar and trusted product to Hispanic consumers seeking culturally resonant health solutions. Bayer noted that as the Hispanic population grows, the brand aims to meet the community’s needs by expanding access to a product already widely recognized throughout Latin America. With a 99% awareness rate in Mexico and 67% of consumers using it regularly, introducing Aspirina in the US underscores the need for culturally familiar products. The company also highlighted persistent disparities in health care and consumer goods access among Hispanic communities, emphasizing that adding Aspirina to its US portfolio places these consumers at the center of its strategy.

For more information: https://www.bayeraspirin.com/

Generic Product

Imatinib Mesylate Tablets

From: Camber

Compare to: Gleevec (Novartis Pharmaceuticals Corporation)

Camber Pharmaceuticals has launched imatinib mesylate tablets, an oral targeted therapy used to treat a range of cancers and disorders driven by specific genetic mutations. It is approved for Philadelphia chromosome–positive chronic myeloid leukemia and acute lymphoblastic leukemia, gastrointestinal stromal tumors, myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome or chronic eosinophilic leukemia, and dermatofibrosarcoma protuberans. The tablets will be offered in 30-count bottles of 400 mg and 90-count bottles of 100 mg.

For more information: https://www.camberpharma.com/