Zydus Lifesciences wins final FDA approval for pulmonary hypertension drug

Zydus Lifesciences Limited (previously Cadila Healthcare Limited) has bagged final approval for Sildenafil for Oral Suspension USP 10 mg/ml, its generic for Revatio, from the United States Food and Drug Administration (FDA).

According to Zydus Lifesciences, Sildenafil for oral suspension is approved for the treatment of high blood pressure in the lungs (pulmonary hypertension). By using the drug, blood vessels in the lungs get relaxed and widened to enable an easier flow of the blood, said the Indian pharma company.

Zydus Lifesciences wins final FDA approval for pulmonary hypertension drug Sildenafil for Oral Suspension USP 10 mg/ml. Photo courtesy of Zydus Cadila.

Zydus Lifesciences stated that reducing high blood pressure in the lungs allows both the heart and lungs to work better and boosts the ability to exercise.

The Indian pharma company will manufacture the drug at its formulation manufacturing facility in Baddi, Himachal Pradesh.

As per IQVIA MAT Aug 2022, the annual sales of Sildenafil for Oral Suspension in the US were $65 million.