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Zydus Lifesciences Share Hits 52-Week High on USFDA Approval for Osteoporosis Drug

Zydus Lifesciences received final USFDA approval to market an estradiol transdermal system.

Shares of Zydus Lifesciences hit a 52-week high in morning trade on April 19 after the company said it had received final approval from the US Food and Drug Administration (USFDA) for its osteoporosis drug.

Zydus Lifesciences received final approval from the US drug regulatory agency to manufacture and market an estradiol transdermal system, USP. The transdermal estradiol is indicated for preventing postmenopausal osteoporosis and will be manufactured at the group’s factory in Moraiya, Ahmedabad.

Estradiol Transdermal System USP, 0.014 mg/day (weekly), with annual sales of $1.9 million in the US.

The group has now received 363 approvals since the application process began in the 2003-04 financial year, with more than 440* ANDAs submitted to date, the company said.

Zydus Lifesciences hit a 52-week high of Rs 519.70 on the BSE to trade at Rs 516.30, up Rs 0.55 or 0.11%.

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