Zydus Lifesciences bags USFDA nod for Sildenafil for Oral Suspension

Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Sildenafil for Oral Suspension USP 10 mg/ml USRLD: Revatio.

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 the 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 the ability to exercise.

The drug will be manufactured at the group's formulation manufacturing facility at Baddi, Himachal Pradesh, India.

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

Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received final approval from the United States Food and Drug Administration (USFDA) to market Bisoprolol Fumarate Tablets USP 5 mg and 10 mg.

Read also: Zydus Lifesciences bags USFDA nod for BP drug Bisoprolol Fumarate