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Zydus Lifesciences Secures USFDA Approval for Menopause Treatment Drug
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News18•21-10-2026, 13:45
Zydus Lifesciences Secures USFDA Approval for Menopause Treatment Drug
- •Zydus Lifesciences received final USFDA approval to market Estradiol and Levonorgestrel Transdermal System.
- •The drug is used to treat moderate to severe menopause symptoms and prevent postmenopausal osteoporosis.
- •The product holds Competitive Generic Therapy designation with eligibility for 180 days of CGT exclusivity.
- •The transdermal patch will be manufactured at the company's facility in Moraiya near Ahmedabad.
- •The medication generated annual sales of approximately USD 45.7 million in the US market according to IQVIA data.
Key Questions Answered
Zydus Lifesciences received final approval from the US Food and Drug Administration (USFDA) to market the generic Estradiol and Levonorgestrel Transdermal System for treating moderate to severe menopause symptoms and preventing postmenopausal osteoporosis.
The product has been designated as a Competitive Generic Therapy and is eligible for 180 days of CGT exclusivity, which begins upon its first commercial marketing.
The approved patch will be manufactured at the group's formulation facility located at Moraiya, near Ahmedabad.
