Zydus Lifesciences gets USFDA’s final nod to market Sildenafil for oral suspension

Zydus Lifesciences 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.

Zydus Lifesciences
Zydus Lifesciences

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.

Sildenafil for Oral Suspension had annual sales of $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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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