Zydus Lifesciences Gets USFDA Nod for Estradiol/Levonorgestrel Transdermal System
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day. This product, used for treating menopausal symptoms and preventing osteoporosis, is designated as a Competitive Generic Therapy (CGT) by the USFDA. Consequently, Zydus is eligible for a 180-day exclusivity period upon its first commercial marketing. The drug had annual sales of approximately USD 45.7 million in the US. The product will be manufactured at Zydus's facility in Moraiya, Gujarat. This approval adds to Zydus's portfolio, bringing their total USFDA ANDA approvals to 458.
Key Highlights
- USFDA grants final approval for Estradiol and Levonorgestrel Transdermal System.
- Product eligible for 180-day Competitive Generic Therapy (CGT) exclusivity.
- Drug used for menopausal symptoms and osteoporosis prevention.
- Annual US sales of the drug were approximately USD 45.7 million.
- Manufacturing to be done at Zydus's Moraiya plant in Gujarat.
Price Impact
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