USFDA nod to Zydus Lifesciences hypertension drug
The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.
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Ahmedabad: Zydus Lifesciences Limited has announced that the company 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).
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).
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