July 24, 2026
Drug Recalls - Availability
Unique Pharmaceutical Laboratories – Recall of cetirizine tablet
July 17, 2026 - Unique Pharmaceutical Laboratories announced a voluntary, consumer level recall of four lots of cetirizine 5 mg tablets due to cross contamination with ranitidine.
Drug Approvals
Lipfendra® (enlicitide) – New drug approval
July 16, 2026 - Merck announced the FDA approval of Lipfendra (enlicitide), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Drug Approvals
Revtorpyk™ (gedatolisib) – New drug approval
July 14, 2026 - Celcuity announced the FDA approval of Revtorpyk (gedatolisib), in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
New Generics
Injectafer® (ferric carboxymaltose) – First-time generic
July 10, 2026 - Viatris launched an AP-rated generic version of American Regent’s Injectafer (ferric carboxymaltose) 100 mg/2 mL and 750 mg/75 mL single-dose vials for injection.
New Generics
Rhofade® (oxymetazoline) – First-time generic
July 20, 2026 - Sun launched an AB-rated generic version of Mayne’s Rhofade (oxymetazoline) cream.
Clinical Updates
Fabhalta® (iptacopan) – Updated indication, accelerated approval converted to traditional approval
July 17, 2026 - Novartis announced the FDA approval of Fabhalta (iptacopan), to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
Clinical Updates
Ryaltris® (olopatadine/mometasone) – Expanded indication
July 7, 2026 - The FDA approved Glenmark’s Ryaltris (olopatadine/ mometasone), for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.