Zydus Lifesciences osteoporosis drug gets USFDA nod, shares soar

Zydus Lifesciences osteoporosis drug gets USFDA nod, shares soar

Zydus Lifesciences reaches 52-week high after receiving final USFDA approval for osteoporosis drug

Zydus Lifesciences achieved a significant milestone on April 19, as the company’s share price reached a 52-week high in early trading. This followed the announcement that the United States Food and Drug Administration (USFDA) had granted final approval for the company’s osteoporosis drug.

The USFDA has given the green light to Zydus Lifesciences to manufacture and market Estradiol Transdermal System USP, which is indicated for the prevention of postmenopausal osteoporosis. The drug will be produced at the group’s facility in Moraiya, Ahmedabad.

Estradiol Transdermal System USP, 0.014 mg/day (weekly) achieved annual sales of $1.9 million in the United States. Zydus Lifesciences now boasts a total of 363 approvals, having filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

In response to the news, Zydus Lifesciences’ share price hit a 52-week high of Rs 519.70 and was trading at Rs 516.30, up Rs 0.55 or 0.11 percent, on the BSE.

This latest development underscores Zydus Lifesciences’ commitment to the development and manufacture of high-quality pharmaceutical products and its ongoing success in securing regulatory approvals for its products.

About Zydus Lifesciences:

Zydus Lifesciences Ltd, previously known as Cadila Healthcare Limited, is a leading Indian multinational pharmaceutical company with its headquarters in Ahmedabad. The company specializes in the production of generic drugs and was ranked 100th on the Fortune India 500 list in 2020.

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