Zydus Cadila gets FDA’s blessing for 2 generics
Zydus Cadila has received the Food and Drug Administration’s green light for two new products — generics of Tracleer and Syprine.
The Tracleer generic (bosentan) was approved in dosage strengths of 62.5 mg and 125 mg. Bosentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance, endothelin-1. This medication blocks the effects of endothelin-1, which helps lower blood pressure in the lungs, slow the worsening of symptoms from the disease and improves ability to exercise.
Zydus Cadila also received the FDA’s clearance for trientine hydrochloride capsules. The product is the generic of Valeant’s Syprine capsules, 250 mg.
Trientine is a chelating agent. It works by removing a heavy metal from the blood. It is used to treat the Wilson’s disease, a genetic metabolic defect that causes excess copper to build up in the body. Trientine is used to treat this inherited condition in people who cannot take penicillamine.
Both products will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.
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