The United States Food and Drug Administration (USFDA) has given Zydus Lifesciences preliminary approval to market Bosentan Tablets for Oral Suspension, 32 mg (USRLD: Tracleer Tablets for Oral Suspension). Bosentan Tablet for Oral Suspension is indicated for the treatment of idiopathic or congenial pulmonary arterial hypertension (PAH) in paediatric patients aged 3 years and older in order to improve pulmonary vascular resistance (PVR). The drug will be produced at the group’s formulation manufacturing facility in Ahmedabad’s SEZ.
In the United States, Bosentan Tablets for Oral Suspension had annual sales of USD 16 million (IQVIA MAT Dec. 2022).
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