homehealthcare NewsZydus Lifesciences receives USFDA approval for generic drug

Zydus Lifesciences receives USFDA approval for generic drug

The drug firm has received final approval from the US Food and Drug Administration (USFDA) to market the drug in multiple strengths, the company said in a regulatory filing.

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By PTI Dec 2, 2022 2:45:13 PM IST (Published)

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Zydus Lifesciences on Friday said it has received approval from the US health regulator to market Estradiol Transdermal System, used to treat moderate to severe symptoms of menopause, in the American market. The drug firm has received final approval from the US Food and Drug Administration (USFDA) to market the drug in multiple strengths, the company said in a regulatory filing.

The medication is indicated to treat moderate to severe symptoms of menopause, which includes feelings of warmth in the face, neck and chest or sudden strong feelings of heat, hot flushes and vaginal dryness in women.
The drug will be manufactured at Zydus group’s formulation manufacturing facility at Moraiya, Ahmedabad.

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