Zydus Lifesciences gets tentative approval from USFDA for Bosentan Tablets for oral suspension

15 Feb 2023 Evaluate

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to market Bosentan Tablets for Oral Suspension, 32 mg (USRLD: Tracleer Tablets for Oral Suspension). The group now has 341 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Bosentan Tablet for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older with idiopathic or congenial PAH to improve pulmonary vascular resistance (PVR). The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.

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

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