India, Oct. 21 -- Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) for its Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day, a generic version of Climara Pro.
The product has been designated as a Competitive Generic Therapy (CGT) and is eligible for a 180-day exclusivity period, subject to applicable US regulatory provisions. The exclusivity period, if applicable, will begin upon the product's first commercial marketing.
The transdermal system is used to treat moderate to severe menopausal symptoms and help prevent osteoporosis in postmenopausal women. It will be manufactured at the group's facility in Moraiya, near Ahmedabad, Gujarat.
According to IQVIA dat...