Viatris: FDA menyetujui Gwyn Lo (norelgestromin/ethinyl estradiol patch)

FDA menyetujui Gwyn Lo, patch kontrasepsi hormonal kombinasi dosis rendah yang baru. Produk ini diharapkan tersedia secara komersial pada akhir tahun ini, menambahkan produk bermerek baru ke portofolio Viatris.

Fakta utama

Diajukan: 6 Agu 2026, 11.56
Peristiwa: Persetujuan FDA
Arah: Positif
Perusahaan: VTRSViatris
Aset: norelgestromin and ethinyl estradiol transdermal system
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 exhibit991-2q26earningsrel.htm EX-99.1 Document Viatris Reports Second-Quarter 2026 Financial Results • Delivers Total Revenues of $3.8 Billion, Representing 5% Reported Growth Compared to Second Quarter 2025 and a U.S. GAAP Net Loss of $119 Million • Total Revenues Were Up 3.5% Operationally Compared to Second Quarter 2025 • Adjusted EBITDA was $1.2 Billion, Up 8% Operationally Compared to Second Quarter 2025 • Advances Key Pipeline Milestones, Including U.S. FDA Approval of Gwyn Lo TM • Announces Sale of Global Rights to Tyrvaya ® • Returns Approximately $550 Million of Capital to Shareholders, Including Through Share Repurchases; Reduces Gross Leverage Ratio to 2.9x • Raises 2026 Financial Guidance Midpoints for All Metrics [1] PITTSBURGH – August 6, 2026 – Viatris I

SEC 8-K