Zydus gets USFDA final approval for Sildenafil for Oral Suspension

3 Oct 2022 , 09:17 AM

Zydus Lifesciences Limited informed that the United States Food and Drug Administration (USFDA) has granted final approval to market Sildenafil for Oral Suspension USP 10 mg/ml USRLD: Revatio.

As per the filing, Sildenafil for oral suspension is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in lungs which allows the blood to flow more easily.

Decreasing high blood pressure in the lungs allows the heart and lungs to work better and improves ability to exercise. The drug will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh, India.

According to the IQVIA MAT Aug 2022 data, Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States.

Further, the group now has 324 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

At around 9:17 AM, Zydus Lifesciences Ltd is currently trading at Rs393.05 per share up by Rs6.35 or 1.64% from its previous closing of Rs386.70 per share on the BSE.

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