August 7, 2026
Drug Approvals
Gwyn Lo™ (norelgestromin/ethinyl estradiol) – New drug approval
July 29, 2026 - Viatris announced the FDA approval of Gwyn Lo (norelgestromin/ethinyl estradiol), for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
New Generics
Nuedexta® (dextromethorphan/quinidine sulfate) – First-time generic
July 30, 2026 - Sun launched an AB-rated generic version of Avanir/Otsuka’s Nuedexta (dextromethorphan/quinidine sulfate) capsules.
New Generics
Priftin® (rifapentine) – First-time generic
July 30, 2026 - Macleods launched an AB-rated generic version of Sanofi’s Priftin (rifapentine) tablets.
Clinical Updates
Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) – New indication
July 31, 2026 - The FDA announced the approval of Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan), in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).