First FDA-Approved Ophthalmic Bevacizumab
On July 24, 2026, the US Food and Drug Administration (FDA) approved Outlook Therapeutics’ Lytenava™ (bevacizumab-vikg), an intravitreal therapy, for the treatment of neovascular age-related macular degeneration (wet AMD). It inhibits vascular endothelial growth factor (VEGF), reducing abnormal retinal blood vessel growth and leakage associated with wet AMD. The approval establishes Lytenava as the first FDA-approved ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD) in the United States, providing an approved ocular formulation of a therapy that has historically been used off-label through repackaged bevacizumab products for retinal diseases. Approval followed a multi-year regulatory review process and was supported by clinical evidence demonstrating efficacy in wet AMD, culminating in an FDA determination that substantial evidence of effectiveness had been established. Lytenava enters a competitive wet AMD market that includes anti-VEGF therapies such as Eylea® (aflibercept), Vabysmo® (faricimab), Lucentis® (ranibizumab), and off-label compounded or repackaged bevacizumab products. The company expects to launch Lytenava before the end of 2026. Here is the prescribing information.
FDA Approves First OTC Tylenol-Naproxen Combination
The FDA approved Tylenol® with naproxen, a fixed-dose over-the-counter (OTC) combination product from Kenvue containing acetaminophen 325mg and naproxen sodium 110mg per tablet for the temporary relief of minor aches and pains in adults and children 12 years of age and older on July 24, 2026. Indications include headache, backache, muscle aches, toothache, menstrual cramps, and minor arthritis pain. Approval was supported by evidence demonstrating the effectiveness and safety of the combination and by eight clinical studies showing superior pain relief compared with acetaminophen alone or naproxen sodium alone. The recommended dosing interval is every 12 hours. Product labeling includes standard acetaminophen-related liver toxicity warnings and nonsteroidal anti-inflammatory drug (NSAID)-related warnings regarding gastrointestinal bleeding and cardiovascular risk. This is the first FDA-approved OTC fixed-dose combination of acetaminophen and naproxen sodium, two analgesics that have long been available separately, and was granted three years of FDA exclusivity. Kenvue expects the product to become available at major US retailers soon.
Generic Bridion Launches
On July 28, 2026, Glenmark Pharmaceuticals announced the launch of sugammadex injection 200mg/2mL and 500mg/5mL single-dose vials, a generic version of Merck’s Bridion®. Sugammadex is a selective relaxant binding agent that helps patients regain normal muscle function more rapidly after surgery following the use of neuromuscular blockers such as rocuronium bromide and vecuronium bromide. It is administered intravenously (IV), with dosing based on the depth of neuromuscular blockade and clinical circumstances. The product is intended primarily for hospital and institutional settings. According to IQVIA, Bridion generated approximately $1.6 billion in sales during the 12 months ending May 2026. Multiple other entrants are expected.
New Low-Estrogen Once Weekly Contraceptive Patch Approved
On July 29, 2026, the FDA approved Viatris’ Gwyn Lo™(norelgestromin/ethinyl estradiol transdermal system), a once-weekly progestin/estrogen combination hormonal contraceptive patch indicated for the prevention of pregnancy in women of childbearing potential with a body mass index (BMI) below 30 kg/m² who are appropriate candidates for combined hormonal contraception. Gwyn Lo delivers norelgestromin 220mcg/day and ethinyl estradiol 20mcg/day through a multilayer matrix transdermal system, providing a low-estrogen, reversible contraceptive option administered once weekly for three consecutive weeks followed by one patch-free week. Approval was supported by demonstrated contraceptive efficacy with a Pearl Index of 4.14 pregnancies per 100 woman-years, while also showing strong real-world performance with only 1.3% of patches fully detaching during the year-long trial. The most commonly reported adverse reactions were application-site reactions, intercycle bleeding, and nausea, while rates of unscheduled bleeding and spotting declined over the course of treatment. Gwyn Lo is contraindicated in women who smoke and are older than 35 years and in women with a BMI 30 kg/m² or greater. Gwyn Lo enters a contraceptive patch market that includes Xulane® (norelgestromin 150mcg/day and ethinyl estradiol 35mcg/day) and Twirla® (levonorgestrel 120mcg/day and ethinyl estradiol 30mcg/day), while also competing broadly with oral contraceptives, vaginal rings, injectable contraceptives, implants, and intrauterine devices. Viatris expects the product to become available later in 2026. Full prescribing information is available here.