homemarket Newsstocks NewsZydus gets USFDA nod to market generic hypertension, anti clotting drugs

Zydus gets USFDA nod to market generic hypertension, anti-clotting drugs

The company received the US regulator's approval for generic drugs apixaban and olmesartan medoxomil and hydrochlorothiazide tablets. Shares of Zydus Lifesciences Ltd ended at Rs 465.55, up by Rs 9.75, or 2.14 percent on the BSE.

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By Jomy Jos Pullokaran  Feb 28, 2023 8:01:52 PM IST (Published)

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Zydus gets USFDA nod to market generic hypertension, anti-clotting drugs

Zydus Lifesciences Ltd on Tuesday, February 28, said the company received final approval from the USFDA to market generic drugs apixaban (2.5 mg and 5 mg), and olmesartan medoxomil & hydrochlorothiazide tablets (20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg).

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Apixaban blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation.


It is also used to reduce the risk of forming blood clots in the legs and lungs of people who have just had hip or knee replacement surgery. It is also used for the treatment of blood clots in the veins of the legs or lungs and reduces the risk of them occurring again.

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad. Apixaban tablets of 2.5 mg and 5 mg had annual sales of $18,876 million in the United States.

Olmesartan medoxomil and hydrochlorothiazide, as the name suggests is a combination of two molecules — olmesartan and hydrochlorothiazide. Olmesartan is an angiotensin II receptor blocker (sometimes called an ARB blocker) while hydrochlorothiazide is a diuretic (water pill).

This combination of medicine is used to treat high blood pressure (hypertension). Lowering blood pressure may lower the risk of a stroke or heart attack. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ.

Olmesartan medoxomil and hydrochlorothiazide tablets had annual sales of $41.7 million in the United States.

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