Drug Approval | February 10, 2025
NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension
TFOS is indicated for the treatment of pulmonary arterial hypertension
TFOS is indicated for the treatment of pulmonary arterial hypertension
WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality
Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
Sales reflect continued strong growth in oncology and vaccines
The company has received five final approvals
The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
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