21-Oct-2026 11:10:15
ZYDUSLIFE : GETS USFDA FINAL APPROVAL FOR TRANSDERMAL SYSTEM WITH 180-DAY CGT EXCLUSIVITY
• USFDA granted final approval for ANDA of Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day • ANDA designated Competitive Generic Therapy; product eligible for 180-day exclusivity available to certain first approved applicants • Exclusivity period, where applicable, would commence upon first commercial marketing • Referenced listed drug is Climara Pro Transdermal System 0.045 mg/0.015 mg per day • Used for moderate to severe menopause symptoms and for osteoporosis prevention in postmenopausal women • To be manufactured at the group's plant at Moraiya, near Ahmedabad, Gujarat; US annual sales ~USD 45.7 mn (IQVIA MAT Aug-2026) • Group now has 458 approvals and has filed 516 ANDAs with USFDA (as on 30-Sept-2026)
Zydus Lifesciences Limited
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